FDA Adverse Event Malfunction Summary report: N

ULTRASAFE X100L PNG CLEAR NVS STEIN

MDR report key: 11484052 · Received March 15, 2021

Report

Report Number: 3009081593-2021-00015
Event Type: Malfunction
Date Received: March 15, 2021
Date of Event: November 13, 2020
Report Date: February 26, 2021
Manufacturer: BECTON DICKINSON HUNGARY KFT (BD)
Product Code: MEG
PMA / PMN Number: SEE H.10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PMA/510(K)#: K011369, K122558. INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR PRE-ACTIVATED DEVICE DETECTED BY END USER. NEITHER SAMPLE NOR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS DID NOT PERFORM A BATCH HISTORY RECORD¿S REVIEW (BHR) BASED ON THE FACTS THAT BATCH RECORD DOES NOT EXTEND TO SYRINGE PRODUCTION AND QUALITY RESULT OVERVIEW IN CASE OF SYRINGE PRODUCTION IS NOT SCOPE BD TATABÁNYA PRODUCTION PROCESS. 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: NO EVIDENCE (SAMPLE, PHOTO, OR ANALYSIS REPORT) WAS PROVIDED THEREFORE NO CONCLUSION COULD BE MADE TO CONFIRM THE REPORTED CONDITION. THE COMPLAINT IS RECORDED FOR TRENDING PURPOSES.

Description of Event or Problem · 1

IT WAS REPORTED THAT ULTRASAFE X100L PNG CLEAR NVS STEIN SAFETY DEVICE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN SHE WENT TO INJECT THE MEDICATION THE PLASTIC PART ON THE OUTSIDE OF THE SYRINGE FELL OFF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
379426	ULTRASAFE X100L PNG CLEAR NVS STEIN	PISTON SYRINGE	MEG	BECTON DICKINSON HUNGARY KFT (BD)		8206727

Patients

Seq	Age	Sex	Outcome	Treatment
1