Devices › Catheter, intravascular, therapeutic, short-term less than 30 days
Device brand name · Picc
Vaxcel Picc: medical device reports filed with FDA
169 reports name it, 2000–2007. Manufacturer given most often on reports: Boston Scientific. Product code FOZ.
- 169
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 82.2%
- classified as malfunction
- 83.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
169 medical device reports received by FDA name the brand "Vaxcel Picc" (picc); the manufacturer given most often on reports is Boston Scientific; received from January 2000 to November 2007. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (82.2%) and injury (17.8%); across all catheter, intravascular, therapeutic, short-term less than 30 days reports (product code FOZ) death is recorded in 0.3% and malfunction in 83.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (36.7%), leak/splash (34.9%) and fracture (28.4%). The patient problems coded most often are therapy/non-surgical treatment, additional, surgical procedure and foreign body, removal of. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Vaxcel Picc was received in the five years to August 2026; the latest was received in November 2007.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 49,301 reports carrying product code FOZ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Replace | 62 | 36.7% | 0.8% |
| Leak/splashthe device leaked | 59 | 34.9% | 21.4% |
| Fracturea broken bone | 48 | 28.4% | 0.9% |
| Explanted | 46 | 27.2% | 0.2% |
| Device, removal of (non-implant) | 17 | 10.1% | 0.7% |
| Hole in material | 16 | 9.5% | 0.4% |
| Crackthe device cracked | 13 | 7.7% | 2.1% |
| Component(s), broken | 11 | 6.5% | 0.2% |
| Shaft, split | 11 | 6.5% | 0% |
| Tears, rips, holes in device, device material | 9 | 5.3% | 0.2% |
| Migration or expulsion of device | 7 | 4.1% | 0.4% |
| Source, detachment from | 7 | 4.1% | 0.1% |
| Breakthe device broke | 6 | 3.6% | 10.9% |
| Implant, removal of | 5 | 3% | 0% |
| Detachment of device component | 4 | 2.4% | 1.6% |
| Difficult to removethe device was hard to remove | 3 | 1.8% | 1.8% |
| Fluid/blood leak | 3 | 1.8% | 6.7% |
| Shaft break | 3 | 1.8% | 0% |
| Cut in material | 2 | 1.2% | 0.1% |
| Noise | 2 | 1.2% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Therapy/non-surgical treatment, additional | 39 | 23.1% |
| Surgical procedure | 30 | 17.8% |
| Foreign body, removal of | 13 | 7.7% |
| Surgical procedure, repeated | 13 | 7.7% |
| Therapy/non-surgical treatment, aborted/stopped | 13 | 7.7% |
| Surgical procedure, additional | 7 | 4.1% |
| Swellingswelling | 7 | 4.1% |
| Migrationthe device moved from where it was placed | 4 | 2.4% |
| Treatment with medication(s) | 3 | 1.8% |
| Deaththe patient died; cause not stated by this term | 2 | 1.2% |
| Edemaswelling from fluid | 2 | 1.2% |
| Extravasation | 2 | 1.2% |
| Hospitalization required | 2 | 1.2% |
| Infiltration into tissue | 2 | 1.2% |
| Thrombus | 2 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Vaxcel Picc | Product code FOZ | All MAUDE reports |
|---|---|---|---|
| Reports | 169 | 49,301 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 17.8% | 13.1% | 36.2% |
| Classified as malfunction | 82.2% | 83.5% | 62.3% |
| Filed by the manufacturer | 97% | 89.6% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code FOZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Insyte AUTOGUARD | 1,314 | 1,050 | 0% |
| BD Insyte Autoguard | 1,246 | 55 | 0% |
| Introcan Safety | 1,255 | 45 | 0.1% |
| Bd Insyte Autog Bc | 695 | 0 | 0% |
| Arrow Cvc Set 3-Lumen 7 Fr X 20 Cm | 1,110 | 123 | 0.1% |
| Arrow Cvc Set 2-Lumen 7 Fr X 20 Cm | 1,406 | 170 | 0.1% |
| Nexiva | 385 | 304 | 0% |
| Mahurkar | 1,046 | 6 | 1.1% |
| BD Nexiva | 372 | 14 | 0% |
| Jelco | 363 | 34 | 0% |
| Arrow Pi Cvc Kit 3-L 7 Fr X 20 Cm Agb | 286 | 63 | 1% |
| Arrow Cvc Set 16 Ga X 8 20 Cm | 551 | 0 | 0% |
| Arrow Cvc Set 3-Lumen 7 Fr X 30 Cm | 338 | 12 | 0% |
| Bd Nexiva Single Port | 224 | 0 | 0% |
| Unspecified Bd Catheter | 251 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Vaxcel Picc reports
How many FDA reports name Vaxcel Picc?
169 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (82.2%) and injury (17.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (36.7%), leak/splash (34.9%), fracture (28.4%), explanted (27.2%) and device, removal of (non-implant) (10.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97%) and voluntary reports (1.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Vaxcel Picc was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.