Device brand name · Surgiphor
BD Surgiphor Sterile Wound Irrigation System: medical device reports filed with FDA
268 reports name it, 2023–2026. Manufacturer given most often on reports: Carefusion. Product code FQH.
- 268
- device reports naming the brand
- 0% of all MAUDE reports · about 77 a year
- 101
- reports, 12 months to August 2026
- 68 in the 12 months before
- 75%
- classified as malfunction
- 92.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 268 reports that name the brand "BD Surgiphor Sterile Wound Irrigation System" (surgiphor), received between January 2023 and August 2026; the manufacturer given most often on reports is Carefusion. Spellings of one product vary from report to report.
101 reports arrived in the 12 months to August 2026, up 49% from 68 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 (75%) and injury (25%); across all lavage, jet reports (product code FQH) death is recorded in 0.1% and malfunction in 92.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are crack (71.3%), contamination (3%) and patient-device incompatibility (1.5%). The patient problems coded most often are post operative wound infection, impaired healing and burning sensation. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 4,932 reports carrying product code FQH. 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 |
|---|---|---|---|
| Crackthe device cracked | 191 | 71.3% | 4.5% |
| Contamination | 8 | 3% | 0.2% |
| Patient-device incompatibilitythe device did not suit the patient | 4 | 1.5% | 0.1% |
| Contamination /decontamination problem | 2 | 0.7% | 0.1% |
| Fungus in device environment | 1 | 0.4% | 0% |
| Leak/splashthe device leaked | 1 | 0.4% | 3.8% |
| Problem with sterilization | 1 | 0.4% | 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 |
|---|---|---|
| Post operative wound infection | 24 | 9% |
| Impaired healingslow healing | 13 | 4.9% |
| Burning sensationa burning feeling | 9 | 3.4% |
| Hypersensitivity/allergic reaction | 8 | 3% |
| Rashskin rash | 5 | 1.9% |
| Hematomaa collection of blood under the skin or in tissue | 3 | 1.1% |
| Purulent discharge | 2 | 0.7% |
| Shockshock, a collapse of the circulation | 1 | 0.4% |
| Wound dehiscencea wound reopened | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | BD Surgiphor Sterile Wound Irrigation System | Product code FQH | All MAUDE reports |
|---|---|---|---|
| Reports | 268 | 4,932 | 26,136,888 |
| Share of that pool | — | 5.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 25% | 6.7% | 36.2% |
| Classified as malfunction | 75% | 92.6% | 62.3% |
| Filed by the manufacturer | 100% | 95.2% | 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 FQH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Fan Spray Kit | 850 | 173 | 0% |
| Hip Kit | 652 | 135 | 0% |
| Elefant suction-irrigation device | 290 | 182 | 0% |
| Versajet Exact Assy 45 Degree X 14mm | 150 | 4 | 0% |
| Zimmer Skin Graft Mesher | 3,463 | 285 | 0% |
| Renasys Touch Device & Power Sup | 447 | 0 | 0% |
| Stryker | 559 | 5 | 1.3% |
| Zimmer Air Dermatome | 2,687 | 372 | 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 BD Surgiphor Sterile Wound Irrigation System reports
How many FDA reports name BD Surgiphor Sterile Wound Irrigation System?
268 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 101 in the latest 12 months.
What kinds of events are reported?
malfunction (75%) and injury (25%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
crack (71.3%), contamination (3%), patient-device incompatibility (1.5%), contamination /decontamination problem (0.7%) and fungus in device environment (0.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that BD Surgiphor Sterile Wound Irrigation System 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.