FDA Adverse Event Malfunction Summary report: N

SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP

MDR report key: 21915073 · Received April 25, 2025

Report

Report Number: 3024508819-2025-00210
Event Type: Malfunction
Date Received: April 25, 2025
Report Date: June 12, 2025
Manufacturer: EMBECTA MEDICAL I LLC - HOLDREGE, NE
Product Code: FMF
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION WAS ADDED TO: CORRECTION TO: E1 (COUNTRY TYPE), H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS) INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. 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. NO DEFINITIVE ROOT CAUSE DETERMINED AT THIS TIME. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

Description of Event or Problem · 0

PRODUCT QUANTITY: PRODUCT: 1, 326725. PRODUCT ISSUE: DAMAGED REDRESSING AREA (DUPLICATE LOT = 1 SP); LOT #: 4100018.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
389566	SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP	SYRINGE, PISTON	FMF	EMBECTA MEDICAL I LLC - HOLDREGE, NE	326725	4100018

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown