FDA Adverse Event Malfunction Summary report: N

BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE

MDR report key: 8430198 · Received March 18, 2019

Report

Report Number: 1213809-2019-00357
Event Type: Malfunction
Date Received: March 18, 2019
Date of Event: February 27, 2019
Report Date: March 15, 2019
Manufacturer: BECTON DICKINSON MEDICAL SYSTEMS
Product Code: FMF
UDI-DI: 30382903095811
PMA / PMN Number: K980987
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DATE OF EVENT: UNKNOWN. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. INVESTIGATION CONCLUSION: BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURES. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE HAD A NEEDLE BREAK. THE FOLLOWING WAS REPORTED, " HEREWITH I LODGE A COMPLAINT FOR THE FOLLOWING PRODUCT: SYRINGE HYPO 3ML A / NEEDLES 25G X 1 '' LUER LOCK TIP (BTE / 100) ITEM # 309581. SOME SYRINGE NEEDLES REMAINED IN PATIENTS' ARMS AFTER INJECTION. I DO NOT KNOW IF IT WOULD COME FROM THE LOT OR THE PRODUCT AS IT IS."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
224225	BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE	PISTON SYRINGE	FMF	BECTON DICKINSON MEDICAL SYSTEMS		UNKNOWN	30382903095811

Patients

Seq	Age	Sex	Outcome	Treatment
0			Other