FDA Adverse Event Injury Summary report: N

BD INTEGRA SYRINGE WITH RETRACTABLE NEEDLE

MDR report key: 1163099 · Received September 16, 2008

Report

Report Number: 1213809-2008-00006
Event Type: Injury
Date Received: September 16, 2008
Report Date: September 16, 2008
Manufacturer: BECTON DICKINSON DIVISION
Product Code: FMF
PMA / PMN Number: K011103
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

SINCE THE DEVICE INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE IF A MALFUNCTION CAUSED OR CONTRIBUTED TO THIS EVENT. THIS DEVICE IS A BD INTEGRA SYRINGE WHICH INCORPORATES A RETRACTING HYPODERMIC NEEDLE AS A SAFETY FEATURE. AFTER INJECTION, THE NEEDLE RETRACTS INTO THE SYRINGE WHEN THE USER FULLY DEPRESSES THE PLUNGER. FULL DETAILS ON THE OPERATION OF THE SYRINGE ARE PROVIDED ON A PROD INSERT INCLUDED IN EACH SHELF CARTON OF SYRINGES. THE RPTR WAS CONTACTED BUT WAS UNABLE TO PROVIDE FURTHER DETAILS. A REVIEW OF THE COMPLAINT DATABASE DID NOT REVEAL ANY PRIOR EVENTS OF THIS TYPE INVOLVING THIS PROD LOT. REG COMPL WILL CONTINUE TO CONDUCT TREND ANALYSIS ON A MONTHLY BASIS TO MONITOR ANY CHANGES.

Description of Event or Problem · 1

RPTR INDICATED THAT AN INJECTION WAS GIVEN TO THE PT IN HIS BUTTOCKS, AND THE NEEDLE PULLED OUT OF THE HUB AND REMAINED IN THE PT. THE PT WENT TO THE NEAREST ER AND THEY TRANSFERRED TO ANOTHER HOSP. RPTR DOES NOT KNOW THE CURRENT STATUS OF THE PT. RPTR DOES NOT KNOW THE EXACT DATE OF THE INCIDENT. THE DEVICE INVOLVED IN THE EVENT WAS DISCARDED IN A SHARPS COLLECTOR AND IS NOT AVAILABLE FOR EVAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BD INTEGRA SYRINGE WITH RETRACTABLE NEEDLE	3ML 22G X 1 1/2" BD INTEGRA SYRINGE	FMF	BECTON DICKINSON DIVISION	NA	5124623

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention