BD PHASEAL¿ INJECTOR LUER LOCK N35J
Report
- Report Number
- 3003152976-2022-00384
- Event Type
- Malfunction
- Date Received
- August 24, 2022
- Date of Event
- July 27, 2022
- Report Date
- November 10, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- ONB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2107015; MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2023; DEVICE MANUFACTURE DATE: 5-AUG-2021. MEDICAL DEVICE LOT #: 2108002; MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2024; DEVICE MANUFACTURE DATE: 25-AUG-2021. MEDICAL DEVICE LOT #: 2110008; MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2024; DEVICE MANUFACTURE DATE: 31-OCT-2021. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 07-NOV-2022 . H6: INVESTIGATION SUMMARY MULTIPLE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO DEFECTS WERE OBSERVED ON THE INJECTORS, HOWEVER, IT WAS NOTED THE MEMBRANE HAD BEEN PUNCTURED SEVERAL TIMES. SOLUTION WAS PUSHED THROUGH THE INJECTORS AND NO LEAKAGES WERE OBSERVED. THE INJECTORS WERE DISASSEMBLED FOR FURTHER EVALUATION, NO ISSUES WERE FOUND ON ANY OF THE PRODUCTS, THE CANNULA WINDOW WAS INSPECTED AND VERIFIED TO MEET REQUIRED SPECIFICATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR INJECTOR LOTS 2107015, 2108002, AND 2110008, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. PRODUCT UNDERGOES A SERIES OF TESTING DURING MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING LEAKAGE TESTING TO VERIFY THE QUALITY OF THE MEMBRANE. TESTING RESULTS WERE REVIEWED FOR THE INJECTOR LOT REPORTED AND NO ISSUES WERE IDENTIFIED, PRODUCT WAS VERIFIED TO MEET REQUIRED SPECIFICATIONS. ALTHOUGH THE SAMPLES HAD BEEN USED, ADDITIONAL TESTING WAS PERFORMED, PENETRATING THE INJECTOR MEMBRANE TEN TIMES, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. BASED ON THE SAMPLE EVALUATION AND OUR INVESTIGATION RESULTS, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.
IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35J WAS FOUND DAMAGED/WORN OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A COMPONENT DAMAGE OF INJECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE INJECTOR WAS FOUND TO BE DAMAGED/WORN OUT AFTER PREPARATION OF SEVERAL DRUGS, WHICH HAS CAUSED THE CONCERN ABOUT LEAKAGE. THE NUMBER OF PUNCTURES IS REPORTED TO BE WITHIN THE RANGE SPECIFIED IN THE PRODUCT PACKAGE INSERT. THE FOLLOWING THREE LOT NUMBERS ARE INVOLVED: LOT# 2107015 ×9, LOT# 2108002 ×1, LOT# 2110008 ×1.
IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35J WAS FOUND DAMAGED/WORN OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A COMPONENT DAMAGE OF INJECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE INJECTOR WAS FOUND TO BE DAMAGED/WORN OUT AFTER PREPARATION OF SEVERAL DRUGS, WHICH HAS CAUSED THE CONCERN ABOUT LEAKAGE. THE NUMBER OF PUNCTURES IS REPORTED TO BE WITHIN THE RANGE SPECIFIED IN THE PRODUCT PACKAGE INSERT. THE FOLLOWING THREE LOT NUMBERS ARE INVOLVED: LOT# 2107015 ×9. LOT# 2108002 ×1. LOT# 2110008 ×1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2325165 | BD PHASEAL¿ INJECTOR LUER LOCK N35J | INTRAVASCULAR ADMINISTRATION SET | ONB | BECTON DICKINSON, S.A. | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |