FDA Adverse Event Malfunction Summary report: N

ULTRASAFE X100L PR PLUM SSL NVS STEIN

MDR report key: 9152493 · Received October 3, 2019

Report

Report Number: 3001741852-2019-00062
Event Type: Malfunction
Date Received: October 3, 2019
Date of Event: September 18, 2019
Report Date: September 25, 2019
Manufacturer: BECTON DICKINSON
Product Code: MEG
PMA / PMN Number: K011369
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
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. PMA/510(K)#: K011369, K060743, K122558. 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: CUSTOMER DOES NOT REQUIRE AN INVESTIGATION. INVESTIGATION CARRIED OUT AT CUSTOMER SITE INDICATES THAT THERE WERE NO ABNORMALITIES WITH THE PRODUCT DETECTED. AND IS LINKED TO END USER ERROR. 8D REPORT IS NOT REQUIRED AT THIS TIME. BATCH RECORD REVIEW DID NOT INDICATE OF ANY INCIDENT IN RELATION TO THE PROBLEM STATEMENT. BATCH WAS RELEASED IN ACCORDANCE TO THE ACCEPTABLE CRITERIA.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ULTRASAFE X100L PR PLUM SSL NVS STEIN EXPERIENCED A BROKEN NEEDLE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PHARMACIST EXPLAINED THAT THE GRAY PART OF THE NEEDLE IS DETACHED FROM THE NEEDLE. INJECTION WAS NOT POSSIBLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
948324	ULTRASAFE X100L PR PLUM SSL NVS STEIN	PEN	MEG	BECTON DICKINSON		1735084

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other