PEN NDL 32G 4MM PRO 100 BOX 1200 US
Report
- Report Number
- 3023359743-2025-00479
- Event Type
- Malfunction
- Date Received
- September 17, 2025
- Report Date
- September 17, 2025
- Manufacturer
- EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
- Product Code
- FMI
- UDI-DI
- 00382903205509
- PMA / PMN Number
- K212015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 2ND COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.
THE CONSUMER REPORTED PEN NEEDLE CLOG WHEN TAKING INJECTIONS. STATED, HE DOES NOT PRIME BEFORE INJECTIONS BECAUSE HE DOES NOT WANT TO WASTE MEDICATION. LOT: 4163056, 4254154 CATALOG: 320550 DATE OF EVENT: UNKNOWN SAMPLES: NO CL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2599331 | PEN NDL 32G 4MM PRO 100 BOX 1200 US | Needle, hypodermic, single lumen | FMI | EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND | 320550 | 4163056 | 00382903205509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |