FDA Adverse Event Malfunction Summary report: N

PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX

MDR report key: 21402212 · Received February 18, 2025

Report

Report Number: 3023359743-2025-00126
Event Type: Malfunction
Date Received: February 18, 2025
Date of Event: January 23, 2025
Report Date: February 18, 2025
Manufacturer: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
Product Code: FMI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
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

PRODUCT NAME: BD MICROFINE PRO 32GX4MM CATALOG NUMBER: 320559; LOT NUMBER: 4003480; QUANTITY: (B)(4) UNIT. [INQUIRIES]: REPORT OF DEFECTIVE PRODUCT (DETAILS). THE PATIENT REPORTED THAT THE NEEDLE DID NOT PUNCTURE THE SKIN AND WAS BROKEN. THE PRODUCT IN QUESTION IS STORED AT THE PHARMACY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
59877	PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX	Needle, hypodermic, single lumen	FMI	EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND	320559	4003480

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Prefer Not To Disclose