FDA Adverse Event Malfunction Summary report: N

BD SAFETYGLIDE¿ NEEDLE

MDR report key: 7158593 · Received January 2, 2018

Report

Report Number: 1213809-2017-00410
Event Type: Malfunction
Date Received: January 2, 2018
Date of Event: December 11, 2017
Report Date: December 15, 2017
Manufacturer: BECTON DICKINSON MEDICAL SYSTEMS
Product Code: FMI
UDI-DI: 30382903059165
PMA / PMN Number: K951254
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: PHOTOS WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCH #6001842 (P/N 305916). THIS COMPLAINT IS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. DHR REVIEW: QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: CAPA (B)(4) WAS OPENED TO ADDRESS THIS ISSUE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS MIXED IN THE SAME SLEEVE TOGETHER, ALL MARKED 1". TWO OF THEM ARE 5/8" AND ONE IS A 1" NEEDLE THIS WAS NOTICED BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2437	BD SAFETYGLIDE¿ NEEDLE	NEEDLE	FMI	BECTON DICKINSON MEDICAL SYSTEMS		6001842	30382903059165

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other