BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
Report
- Report Number
- 1917413-2023-01110
- Event Type
- Malfunction
- Date Received
- October 31, 2023
- Date of Event
- October 13, 2023
- Report Date
- December 1, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- UDI-DI
- 30382903627951
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2321329, D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2023, H4. DEVICE MANUFACTURE DATE: 17-NOV-2022. D4. MEDICAL DEVICE LOT #: 3111753, D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2024, H4. DEVICE MANUFACTURE DATE: 21-APR-2023. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION SUMMARY: BD RECEIVED 13 SAMPLES FOR LOT # 3111753 FOR INVESTIGATION. NO SAMPLES WERE RECEIVED FOR LOT 2321329. VISUAL EXAMINATION OF THE SAMPLES INDICATED GEL AIR BUBBLES. ADDITIONALLY, 100 RETENTION SAMPLES FROM LOT 3111753 AND 88 RETENTION SAMPLES FROM LOT 2321329 WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF OCTOBER 2023. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 HAS BEEN CONFIRMED FOR GEL AIR BUBBLES FOR LOT 3111753. BD WAS UNABLE TO CONFIRM GEL AIR BUBBLES FOR LOT 2321329. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES D9: RETURNED TO MANUFACTURER ON: 28-NOV-2023.
IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE WERE AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR BLOOD DONATION TEAMS ARE ISOLATING EFFECTED TUBES THAT THEY IDENTIFY WITHIN THE STOCK FOUND IN THEIR STOCKS ON A DAILY BASIS AND ALTHOUGH NUMBERS ARE STILL LOW, AIR IN GEL HAS NOW BEEN SEEN IN THE FOLLOWING LOTS: 2321329, 3111753.
IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE WERE AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR BLOOD DONATION TEAMS ARE ISOLATING EFFECTED TUBES THAT THEY IDENTIFY WITHIN THE STOCK FOUND IN THEIR STOCKS ON A DAILY BASIS AND ALTHOUGH NUMBERS ARE STILL LOW, AIR IN GEL HAS NOW BEEN SEEN IN THE FOLLOWING LOTS: 2321329, 3111753.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2226276 | BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | SEE H10 | 30382903627951 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |