BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
Report
- Report Number
- 1024879-2019-00956
- Event Type
- Malfunction
- Date Received
- June 4, 2019
- Date of Event
- May 17, 2019
- Report Date
- June 28, 2019
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679886
- PMA / PMN Number
- BK050036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR CONDENSATION WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND CONDENSATION WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR CONDENSATION WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ADDITIONALLY, THE PHOTOS DID NOT IDENTIFY A SPECIFIC PRODUCT ISSUE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT 1 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE FROM LOT # 9052964, 1 TUBE FROM LOT # 9066902, AND 1 TUBE FROM LOT # 9088522 HAD CONDENSATION IN THEM AND APPEARED "ABNORMAL" DUE TO POOR BARRIER SEPARATION OF THE GEL AFTER CENTRIFUGATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENTS LAST TWO BOXES OF SST THEY RECEIVED HAVE BEEN ABNORMAL. THERE¿S CONDENSATION AND WHEN THE SPECIMENS ARE SPUN THEY DO NOT LOOK NORMAL.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9052964, MEDICAL DEVICE EXPIRATION DATE: 2020-02-29, DEVICE MANUFACTURE DATE: 2019-02-21. MEDICAL DEVICE LOT #: 9066902, MEDICAL DEVICE EXPIRATION DATE: 2020-02-29, DEVICE MANUFACTURE DATE: 2020-02-29. MEDICAL DEVICE LOT #: 9088522, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2019-03-29. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT 1 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE FROM LOT # 9052964, 1 TUBE FROM LOT # 9066902, AND 1 TUBE FROM LOT # 9088522 HAD CONDENSATION IN THEM AND APPEARED "ABNORMAL" DUE TO POOR BARRIER SEPARATION OF THE GEL AFTER CENTRIFUGATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CLIENTS LAST TWO BOXES OF SST THEY RECEIVED HAVE BEEN ABNORMAL. THERE¿S CONDENSATION AND WHEN THE SPECIMENS ARE SPUN THEY DO NOT LOOK NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 460515 | BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | SEE SECTION H.10. | 50382903679886 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |