FDA Adverse Event Malfunction Summary report: N

PEN NDL 32G 4MM PRO 100 BOX 1200 US

MDR report key: 23075066 · Received September 17, 2025

Report

Report Number: 3023359743-2025-00480
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

Additional Manufacturer Narrative · 0

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 1ST 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.

Description of Event or Problem · 0

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
1732261	PEN NDL 32G 4MM PRO 100 BOX 1200 US	Needle, hypodermic, single lumen	FMI	EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND	320550	4254154	00382903205509

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown