BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG
Report
- Report Number
- 1917413-2021-01081
- Event Type
- Malfunction
- Date Received
- December 22, 2021
- Date of Event
- November 29, 2021
- Report Date
- May 31, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- UDI-DI
- 50382903627887
- PMA / PMN Number
- K972075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1098398. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2021-04-08. MEDICAL DEVICE LOT #: 1137325. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2021-05-17. MEDICAL DEVICE LOT #: 1014023. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2021-01-14. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 19-APR-2022. H.6. INVESTIGATION: BD RECEIVED 10 SAMPLES FROM EACH LOT AND 4 PHOTOS (LOTS 1098398 AND 1014023) WERE RECEIVED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. RETENTION SAMPLES WERE INSPECTED AND NO DEFECTS WERE FOUND. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED FOR THE REPORTED DEFECT. THE SAMPLES WERE TESTED AND UPON COMPLETION, THE INDICATED FAILURE MODE WAS NOT OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE, POOR BARRIER, BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. EVALUATION OF BOTH CUSTOMER RETURNS AND CONTROL SAMPLES TESTED WAS ACCEPTABLE. ALL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED AS EXPECTED. 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 POOR BARRIER SEPARATION FOR LOT #'S 1098398 AND 1014023 BASED ON THE PHOTOS PROVIDED. LOT 1137325 WAS UNABLE TO BE CONFIRMED. ALL TESTING OF RETENTION SAMPLES AND CUSTOMER RETURN SAMPLES WAS SATISFACTORY. BD WAS UNABLE TO DETERMINE A ROOT CAUSE.
H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT 4PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER WAS OBSERVED ON LOTS 1098398 AND 1014023. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR POOR BARRIER WAS NOT OBSERVED. TESTING WAS PERFORMED ON LOT 1014023 DUE TO LOTS 1098398 AND 1137325 WERE EXPIRED AT THE TIME OF THE COMPLAINT BEING FILED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE, POOR BARRIER (INCLUDING FIBRIN STRANDS/FIBRIN CLOTS/FIBRIN MASS) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. EVALUATION OF BOTH RETAIN AND CONTROL SAMPLES TESTED WAS ACCEPTABLE. ALL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED AS EXPECTED. 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 THE INDICATED FAILURE MODE POOR BARRIER BASED ON PHOTOS ONLY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAS POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED A FAILURE IN MATERIAL SEGREGATION IN THE SEPARATOR GEL OF THE TUBES. "
IT WAS REPORTED THAT BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAS POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED A FAILURE IN MATERIAL SEGREGATION IN THE SEPARATOR GEL OF THE TUBES. "
IT WAS REPORTED THAT BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAS POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED A FAILURE IN MATERIAL SEGREGATION IN THE SEPARATOR GEL OF THE TUBES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1958702 | BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 362788 | SEE H.10. | 50382903627887 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |