BD PHASEAL OPTIMA INJECTOR (N35-O)
Report
- Report Number
- 3003152976-2021-00773
- Event Type
- Malfunction
- Date Received
- November 22, 2021
- Date of Event
- October 25, 2021
- Report Date
- December 2, 2021
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- ONB
- UDI-DI
- 00382905150524
- PMA / PMN Number
- K181221
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. CONCOMITANT MED PROD DATE: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT.
H6: INVESTIGATION SUMMARY: PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION SOME OPTIMA INJECTORS AND CONNECTORS ARE OBSERVED. HOWEVER; BASED ON PICTURES RECEIVED NO DAMAGES OR ISSUES COULD BE OBSERVED ON OPTIMA COMPONENTS THAT COULD BE RELATED TO THE EVENT REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2107503 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. A DEVICE HISTORY REVIEWED FROM LOT 1911102 (ASSEMBLY LOT 1911102) WAS REVIEWED AND IT IS NOTICED THAT THE EXPIRATION DATE WAS 31 OCTOBER 2020. THEREFORE; THE PRODUCT WAS EXPIRED AT THE MOMENT OF IT IS USE. SINCE THE SHELF LIFE WAS EXCEEDED, THE PROPER PRODUCT FUNCTIONALITY COULD NOT BE ENSURED. FIVE RETAINED SAMPLES FROM WERE EVALUATED. SINCE OPTIMA INJECTOR LOT PROVIDED 1911102 (MATERIAL REFERENCE 515052) WAS EXPIRED, RETAINED SAMPLES WERE NOT REQUESTED AS THE PROPER FUNCTIONALITY OF THE PRODUCT COULD NOT BE ENSURED. THEREFORE; FIVE RETAINED SAMPLES FROM OPTIMA INJECTOR LOT 2102316 WERE REQUESTED TO BE TESTED AGAINST OPTIMA RETAINED CONNECTORS FROM LOT 2107503. LUER LOCK MEASURED, NO DAMAGE OR DEFECTS OBSERVED, MEASUREMENTS MET ACCEPTANCE CRITERIA. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND ALL PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. IT SHOULD BE CONSIDERED THAT INJECTOR/CONNECTOR SEPARATION FAILURE MODE IS A DRY DISCONNECT WHICH PREVENTS LEAKAGE BY DESIGN. IT IS RECOMMENDED TO USE THE OPTIONAL M25-O CLAMP TO AVOID DRY DISCONNECTS DURING USE.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. CONCOMITANT MED PROD DATE: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT.
IT WAS REPORTED THAT BD INJECTOR N35-O HAD THE INJECTOR AND MATING COMPONENT SEPARATE.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHASEAL OPTIMA INJECTOR AND CONNECTOR DISCONNECTED EASILY WHILE INFUSING ON A PATIENTG".
IT WAS REPORTED THAT BD INJECTOR N35-O HAD THE INJECTOR AND MATING COMPONENT SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHASEAL OPTIMA INJECTOR AND CONNECTOR DISCONNECTED EASILY WHILE INFUSING ON A PATIENT."
IT WAS REPORTED THAT BD INJECTOR N35-O HAD THE INJECTOR AND MATING COMPONENT SEPARATE.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHASEAL OPTIMA INJECTOR AND CONNECTOR DISCONNECTED EASILY WHILE INFUSING ON A PATIENTG".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1753833 | BD PHASEAL OPTIMA INJECTOR (N35-O) | INTRAVASCULAR ADMINISTRATION SET | ONB | BECTON DICKINSON, S.A. | 2107503 | 00382905150524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | CONNECTOR C35-O |