FDA Adverse Event Malfunction Summary report: N

ULTRASAFE X100L PR PLUM SSL NVS STEIN

MDR report key: 9617185 · Received January 22, 2020

Report

Report Number: 3001741852-2020-00008
Event Type: Malfunction
Date Received: January 22, 2020
Date of Event: December 10, 2019
Report Date: January 15, 2020
Manufacturer: BECTON DICKINSON
Product Code: MEG
PMA / PMN Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1771817; EXPIRATION DATE: 2023-05-04; MANUFACTURE DATE: 2018-05-10. MEDICAL DEVICE LOT #: 1753135; \EXPIRATION DATE: 2023-03-20; \MANUFACTURE DATE: 2018-04-03. \ INVESTIGATION SUMMARY: UNCONFIRMED, NO SAMPLE RECEIVED. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER BUT NOT CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS. ROOT CAUSE DESCRIPTION: BATCH RECORD REVIEW DID NOT INDICATE OF ANY INCIDENT IN RELATION TO THE PROBLEM STATEMENT. BATCH WAS RELEASED IN ACCORDANCE TO THE ACCEPTABLE CRITERIA. COMPLAINT COULD POTENTIALLY BE RELATED TO A LOOSE PLUNGER.

Description of Event or Problem · 1

IT WAS REPORTED THAT ULTRASAFE X100L PR PLUM SSL NVS STEIN PLUNGER FELL OUT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PICKED UP THE SYRINGE FROM THE PACKAGING AND THE PLUNGER FELL OUT AND THE MEDICATION FELL OUT. LOOSE PLUNGER, BASED ON SAMPLE EVALUATION NO INDICATIONS FOR A TECHNICAL DEFECT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
82785	ULTRASAFE X100L PR PLUM SSL NVS STEIN	ULTRASAFE	MEG	BECTON DICKINSON		SEE H.10

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other