FDA Adverse Event Malfunction Summary report: N

SYRINGE 0.3ML 31G 6MM 30BOX MEX

MDR report key: 21332944 · Received February 7, 2025

Report

Report Number: 9614033-2025-05003
Event Type: Malfunction
Date Received: February 7, 2025
Date of Event: January 13, 2025
Report Date: June 26, 2025
Manufacturer: BECTON DICKNSON - DE MEXICO
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: B4, G6, H2, H11. INVESTIGATION SUMMARY: ADDITIONAL INFORMATION RECEIVED, SITUATION ANALYSIS (B)(4) AND CAPA PR-00048 WERE OPENED TO ADDRESS THIS COMPLAINT.

Additional Manufacturer Narrative · 0

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

PHARMAPLUS HAS REJECTED 3 PRODUCT DELIVERIES IN MEXICO DUE TO DIVERGENCE IN THE EXPIRATION DATES OF THE PRODUCT FOUND ON THE INVOICE AND ON THE PRODUCT. 326785/ BATCH 4179013.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1248320	SYRINGE 0.3ML 31G 6MM 30BOX MEX	SYRINGE, PISTON	FMF	BECTON DICKNSON - DE MEXICO	326785	4179013

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown