Devices › Needle, hypodermic, single lumen
Device brand name · Needle hypodermic single lumen
Pen Ndl 32g 4mm Pro 100 Box 1200 Us: medical device reports filed with FDA
510 reports name it, 2021–2025. Manufacturer given most often on reports: Embecta Penel - Dun Laoghaire Ireland. Product code FMI.
- 510
- device reports naming the brand
- 0% of all MAUDE reports · about 102 a year
- 9
- reports, 12 months to August 2026
- 230 in the 12 months before
- 99.8%
- classified as malfunction
- 87.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
510 medical device reports received by FDA name the brand "Pen Ndl 32g 4mm Pro 100 Box 1200 Us" (needle hypodermic single lumen); the manufacturer given most often on reports is Embecta Penel - Dun Laoghaire Ireland; received from July 2021 to September 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
9 reports arrived in the 12 months to August 2026, down 96% from 230 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 (99.8%) and injury (0.2%); across all needle, hypodermic, single lumen reports (product code FMI) death is recorded in 0.2% and malfunction in 87.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to deliver (83.3%), misconnection (11%) and off-label use (10.4%). The patient problems coded most often are foreign body in patient, hyperglycemia and needle stick/puncture. 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 39,876 reports carrying product code FMI. 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 |
|---|---|---|---|
| Failure to deliverthe device did not deliver the dose or item | 425 | 83.3% | 17.5% |
| Misconnection | 56 | 11% | 2.8% |
| Off-label use | 53 | 10.4% | 0.4% |
| Breakthe device broke | 27 | 5.3% | 12.7% |
| No flow | 23 | 4.5% | 0.7% |
| Defective devicethe device was defective | 15 | 2.9% | 2.9% |
| Leak/splashthe device leaked | 14 | 2.7% | 8.5% |
| Delivered as unsterile product | 7 | 1.4% | 0.7% |
| Device markings/labelling problema problem with the device markings or label | 2 | 0.4% | 2.2% |
| Material protrusion/extrusion | 2 | 0.4% | 1.3% |
| Packaging problem | 2 | 0.4% | 1.2% |
| Device contamination with chemical or other material | 1 | 0.2% | 5.4% |
| Incomplete or missing packaging | 1 | 0.2% | 0.1% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 3 | 0.6% |
| Hyperglycemiahigh blood sugar | 3 | 0.6% |
| Needle stick/puncture | 2 | 0.4% |
| Painpain, site not specified | 2 | 0.4% |
| Ecchymosis | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pen Ndl 32g 4mm Pro 100 Box 1200 Us | Product code FMI | All MAUDE reports |
|---|---|---|---|
| Reports | 510 | 39,876 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 0.2% | 10.5% | 36.2% |
| Classified as malfunction | 99.8% | 87.6% | 62.3% |
| Filed by the manufacturer | 100% | 92.1% | 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 FMI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unspecified Bd Pen Needle | 1,820 | 0 | 0.1% |
| BD Vacutainer Eclipse Blood Collection Needle | 2,116 | 627 | 0% |
| Bd Safetyglide Needle | 1,258 | 3 | 0% |
| Bd Precisionglide Needle | 1,229 | 0 | 0% |
| Bd Nano 2nd Gen Pen Needle | 788 | 0 | 0% |
| Bd Ultra Fine Pen Needles | 656 | 0 | 0% |
| BD SafetyGlide | 576 | 127 | 0% |
| Ez-Io Power Driver | 463 | 0 | 2.2% |
| BD Vacutainer Eclipse Blood Collection Needle with Pre-Attached Holder | 423 | 18 | 0% |
| Bd Ultra Fine Pen Needle | 375 | 0 | 0% |
| Bd Safetyglide Needle Only 25 G | 328 | 0 | 0% |
| Unspecified Bd Needle | 327 | 0 | 0% |
| Bd Ultra-Fine Pen Needle | 320 | 0 | 0% |
| Magellan | 330 | 20 | 0% |
| Bd Vacutainer Flashback Blood Collection Needle | 519 | 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 Pen Ndl 32g 4mm Pro 100 Box 1200 Us reports
How many FDA reports name Pen Ndl 32g 4mm Pro 100 Box 1200 Us?
510 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.
What kinds of events are reported?
malfunction (99.8%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to deliver (83.3%), misconnection (11%), off-label use (10.4%), break (5.3%) and no flow (4.5%). 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 Pen Ndl 32g 4mm Pro 100 Box 1200 Us 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.