FDA Adverse Event Malfunction Summary report: N

BD ULTRASAFE PASSIVE NEEDLE GUARD SYRINGE

MDR report key: 9638220 · Received January 28, 2020

Report

Report Number: 3009081593-2020-00006
Event Type: Malfunction
Date Received: January 28, 2020
Date of Event: December 11, 2019
Report Date: January 9, 2020
Manufacturer: BECTON DICKINSON HUNGARY KFT (BD)
Product Code: MEG
PMA / PMN Number: SEE H.10
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INITIAL REPORTER PHONE #: UNKNOWN. PMA / 510(K)#: K011369 AND K122558. INVESTIGATION SUMMARY: NEITHER SAMPLE, NOR PHOTO WAS PROVIDED TO BD MEDICAL PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. DURING THE YEARS OF INVESTIGATION OF COMPLAINTS ABOUT PRE-ACTIVATED DEVICES SEVERAL ROOT CAUSES WERE DISCOVERED WHICH WERE WITHIN THE CUSTOMER¿S SPHERE OF INFLUENCE. BEST PRACTICES AND GUIDELINES WERE COLLECTED, AND SUMMARIZED IN STAN-010. ROOT CAUSE DESCRIPTION: BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS. RATIONALE: COMPLAINT IS UNCONFIRMED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE SAFETY DEVICE WAS DEFECTIVE WITH A BD ULTRASAFE¿ PASSIVE NEEDLE GUARD SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPRING WAS DEFECTIVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
103401	BD ULTRASAFE PASSIVE NEEDLE GUARD SYRINGE	PISTON SYRINGE	MEG	BECTON DICKINSON HUNGARY KFT (BD)		8128662

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other