BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E
Report
- Report Number
- 1917413-2021-01086
- Event Type
- Malfunction
- Date Received
- December 28, 2021
- Date of Event
- December 2, 2021
- Report Date
- February 24, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- PJE
- UDI-DI
- 50382903627887
- PMA / PMN Number
- K972075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE EXPIRED TUBES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E THE TUBE WAS USED AFTER THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT EXPIRED TUBES WERE USED. PER EMAIL: YESTERDAY ONE OF OUR SITES HAD AN INVENTORY ISSUE AND HAD TO USE PPT VACUTAINER TUBE PRLWH 13X100(PK/100) TUBES THAT EXPIRED ON NOVEMBER 30, 2021. EFFECTIVELY THEY WERE USED TO COLLECT A SPECIMEN WITHIN 24 HOURS OF THE EXPIRY DATE. THE LOT NUMBER IS 0316256, EXPIRY 2021-11-30, PART NUMBER BD 362788. CAN YOU ADVISE AS SOON AS POSSIBLE IF BD HAS ANY DOCUMENTATION THAT WOULD SUPPORT THE EFFICACY OF THESE TUBES PAST THE EXPIRY DATE? IF THERE IS ANY DOCUMENTATION ON THE IMPACT / RISK OF USING A TUBE THAT IS 1 DAY EXPIRED ON THE TEST RESULTS OF THE SAMPLE WITHIN THE TUBE IT WOULD BE CRITICAL. AT PRESENT ALL DONATIONS COLLECTED USING THESE TUBES ARE CURRENTLY IN PHYSICAL QUARANTINE AT CBS PENDING YOUR CONFIRMATION.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E THE TUBE WAS USED AFTER THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT EXPIRED TUBES WERE USED. PER EMAIL: YESTERDAY ONE OF OUR SITES HAD AN INVENTORY ISSUE AND HAD TO USE PPT VACUTAINER TUBE PRLWH 13X100(PK/100) TUBES THAT EXPIRED ON NOVEMBER 30, 2021. EFFECTIVELY THEY WERE USED TO COLLECT A SPECIMEN WITHIN 24 HOURS OF THE EXPIRY DATE. THE LOT NUMBER IS 0316256, EXPIRY 2021-11-30, PART NUMBER BD 362788. CAN YOU ADVISE AS SOON AS POSSIBLE IF BD HAS ANY DOCUMENTATION THAT WOULD SUPPORT THE EFFICACY OF THESE TUBES PAST THE EXPIRY DATE? IF THERE IS ANY DOCUMENTATION ON THE IMPACT / RISK OF USING A TUBE THAT IS 1 DAY EXPIRED ON THE TEST RESULTS OF THE SAMPLE WITHIN THE TUBE IT WOULD BE CRITICAL. AT PRESENT ALL DONATIONS COLLECTED USING THESE TUBES ARE CURRENTLY IN PHYSICAL QUARANTINE AT CBS PENDING YOUR CONFIRMATION.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E THE TUBE WAS USED AFTER THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT EXPIRED TUBES WERE USED. PER EMAIL: YESTERDAY ONE OF OUR SITES HAD AN INVENTORY ISSUE AND HAD TO USE PPT VACUTAINER TUBE PRLWH 13X100(PK/100) TUBES THAT EXPIRED ON NOVEMBER 30, 2021. EFFECTIVELY THEY WERE USED TO COLLECT A SPECIMEN WITHIN 24 HOURS OF THE EXPIRY DATE. THE LOT NUMBER IS 0316256, EXPIRY 2021-11-30, PART NUMBER BD 362788. CAN YOU ADVISE AS SOON AS POSSIBLE IF BD HAS ANY DOCUMENTATION THAT WOULD SUPPORT THE EFFICACY OF THESE TUBES PAST THE EXPIRY DATE? IF THERE IS ANY DOCUMENTATION ON THE IMPACT / RISK OF USING A TUBE THAT IS 1 DAY EXPIRED ON THE TEST RESULTS OF THE SAMPLE WITHIN THE TUBE IT WOULD BE CRITICAL. AT PRESENT ALL DONATIONS COLLECTED USING THESE TUBES ARE CURRENTLY IN PHYSICAL QUARANTINE AT CBS PENDING YOUR CONFIRMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1990189 | BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E | BLOOD SPECIMEN COLLECTION DEVICE | PJE | BECTON, DICKINSON & CO. (BROKEN BOW) | 362788 | 0316256 | 50382903627887 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |