FDA Adverse Event Malfunction Summary report: N

SYRINGE 0.3ML 29GA 1/2IN

MDR report key: 12415451 · Received September 2, 2021

Report

Report Number: 1920898-2021-00953
Event Type: Malfunction
Date Received: September 2, 2021
Date of Event: July 26, 2021
Report Date: August 20, 2021
Manufacturer: BD MEDICAL - DIABETES CARE
Product Code: FMF
PMA / PMN Number: K024112
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION SUMMARY : EXEC SUMMARY - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND THIS IS THE 10TH RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 0160988. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CAPA/SA - BASED ON THE ABOVE NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

Description of Event or Problem · 1

IT WAS REPORTED THAT 2 BD SYRINGE 0.3ML 29GA 1/2IN HUBS SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT THE NEEDLE AND SHIELD SEPARATION FROM THE BARREL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1313532	SYRINGE 0.3ML 29GA 1/2IN	PISTON SYRINGE	FMF	BD MEDICAL - DIABETES CARE		0160988

Patients

Seq	Age	Sex	Outcome	Treatment
1