FDA Adverse Event Malfunction Summary report: N

PEN NDL 32GA 4MM 14BAG 700CASE JP

MDR report key: 19383430 · Received May 23, 2024

Report

Report Number: 3023359743-2024-00110
Event Type: Malfunction
Date Received: May 23, 2024
Date of Event: April 30, 2024
Report Date: May 23, 2024
Manufacturer: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
Product Code: FMI
PMA / PMN Number: UNKNOWN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

70 PEN NEEDLES IMPACTED FROM AN UNKNOWN LOT. SEE MEDWATCH COMPLETED SECTION C ATTACHED. 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. 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. DEVICE IS NOT AVAILABLE.

Description of Event or Problem · 0

WHEN DID IT OCCUR? : BEFORE USE HYPODERMIC NEEDLE INJURY: UNKNOWN OTHER TREATMENT: UNKNOWN WERE THE RETURNED ITEMS USED? : NO IF THEY WERE USED, WAS SOMETHING ATTACHED TO THEM? : NO RETURNED QUANTITY: NONE DETAILS OF OCCURRENCE(TIMELINE, HISTORY, ETC.): TRIED TO INJECT WITH INSULIN PEN ATTACHED, BUT COULDN'T (B)(4) UNITS¿70 UNITS RANGE) COULD NOT BE USED. BATCH #: UNKNOWN

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
604351	PEN NDL 32GA 4MM 14BAG 700CASE JP	Needle, hypodermic, single lumen	FMI	EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND	320136	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown