FDA Adverse Event Malfunction Summary report: N

SYRINGE 0.3ML 31G 6MM S/C U-100 RELION

MDR report key: 21559425 · Received March 10, 2025

Report

Report Number: 3024508819-2025-00128
Event Type: Malfunction
Date Received: March 10, 2025
Date of Event: February 12, 2025
Report Date: April 21, 2025
Manufacturer: EMBECTA MEDICAL I LLC - HOLDREGE, NE
Product Code: FMF
UDI-DI: 00681131138383
PMA / PMN Number: K212499
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (COMPONENT CODE, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

Description of Event or Problem · 0

PET OWNER REPORTED FOUND 1 SYRINGE THE TIP OF NEEDLE WAS HOOKED AND WOULD NOT DRAW UP INSULIN. DC. LOT # 4030019 CATALOG# 328521 DATE OF EVENT 02/12/2025 SAMPLE STATUS AWAITING SAMPLE NO REPLACEMENTS SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1451032	SYRINGE 0.3ML 31G 6MM S/C U-100 RELION	SYRINGE, PISTON	FMF	EMBECTA MEDICAL I LLC - HOLDREGE, NE	328521	4030019	00681131138383

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown