ULTRASAFE X100L PR PLUM SSL NVS STEIN

Report

Report Number: 3001741852-2019-00009
Event Type: Malfunction
Date Received: April 24, 2019
Date of Event: April 8, 2019
Report Date: May 9, 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 · 0

INVESTIGATION: BATCH RECORD REVIEW DID NOT INDICATE OF ANY INCIDENT IN RELATION TO THE PROBLEM STATEMENT. BATCH WAS RELEASED IN ACCORDANCE TO THE ACCEPTABLE CRITERIA. A FULL ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED WITH THE AVAILABLE INFORMATION AS NO SAMPLE OR PHOTOS WERE RETURNED. 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE ULTRASAFE X100L PR PLUM SSL NVS STEIN EXPERIENCED A LOOSE PLUNGER. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: SYRINGE IS LEAKING, THE PLUNGER WAS NOT ATTACHED PROPERLY.

Additional Manufacturer Narrative · 1

DATE OF EVENT: UNKNOWN. PMA/510(K)#: K011369, K060743, K122558. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ULTRASAFE X100L PR PLUM SSL NVS STEIN EXPERIENCED A LOOSE PLUNGER. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: SYRINGE IS LEAKING, THE PLUNGER WAS NOT ATTACHED PROPERLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
336024	ULTRASAFE X100L PR PLUM SSL NVS STEIN	SAFETY SYRINGE	MEG	BECTON DICKINSON		9549052

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other