BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2023-00161
- Event Type
- Malfunction
- Date Received
- February 10, 2023
- Date of Event
- January 30, 2023
- Report Date
- August 2, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679558
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 2 LOTS OF BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD GEL SMEARING ON SIDES OF TUBE AND ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED EMAIL FROM OUR DEPT OF LAB MEDICINE (DLM), THAT WE HAVE ENCOUNTERED SOME ANALYTICAL ISSUES ON MONDAY ¿ 30 JAN 2023, AND OUR DLM FOUND THAT THE AFFECTED SAMPLE TUBES HAD SOME GELATINOUS SUBSTANCE ON THE SIDES OF THE TUBES. H.6 ADDITIONAL IMDRF ANNEX A CODE: A0908.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2112278. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2023. DEVICE MANUFACTURE DATE: 22-APR-2022. MEDICAL DEVICE LOT #: 2126976. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2023. DEVICE MANUFACTURE DATE: 06-MAY-2022. 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 HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR GEL SMEARING WAS NOT OBSERVED; PHOTO WAS UNCLEAR. ERRONEOUS RESULTS CANNOT BE EVALUATED THROUGH PHOTOS, CLINICAL TESTING WAS PERFORMED. RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR CLINICAL EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO ERRONEOUS RESULTS OR GEL SMEARING WAS OBSERVED: THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODES (GEL SMEARING AND ERRONEOUS RESULTS-CREATININE KINASE) VIA CLINICAL INVESTIGATION BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETENTION AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. REPLICATES OF BOTH RETENTION AND CONTROL SAMPLES WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. 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 GEL SMEARING AND ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES. FACTORS THAT MAY CONTRIBUTE TO GEL SMEARING AND ERRONEOUS RESULTS WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT 2 LOTS OF BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD GEL SMEARING ON SIDES OF TUBE AND ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED EMAIL FROM OUR DEPT OF LAB MEDICINE (DLM), THAT WE HAVE ENCOUNTERED SOME ANALYTICAL ISSUES ON MONDAY ¿ 30 JAN 2023, AND OUR DLM FOUND THAT THE AFFECTED SAMPLE TUBES HAD SOME GELATINOUS SUBSTANCE ON THE SIDES OF THE TUBES.
IT WAS REPORTED THAT 2 LOTS OF BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD GEL SMEARING ON SIDES OF TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED EMAIL FROM OUR DEPT OF LAB MEDICINE (DLM), THAT WE HAVE ENCOUNTERED SOME ANALYTICAL ISSUES ON MONDAY ¿ (B)(6) 2023 AND OUR DLM FOUND THAT THE AFFECTED SAMPLE TUBES HAD SOME GELATINOUS SUBSTANCE ON THE SIDES OF THE TUBES.
IT WAS REPORTED THAT 2 LOTS OF BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD GEL SMEARING ON SIDES OF TUBE AND ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED EMAIL FROM OUR DEPT OF LAB MEDICINE (DLM), THAT WE HAVE ENCOUNTERED SOME ANALYTICAL ISSUES ON MONDAY ¿ 30 JAN 2023, AND OUR DLM FOUND THAT THE AFFECTED SAMPLE TUBES HAD SOME GELATINOUS SUBSTANCE ON THE SIDES OF THE TUBES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54342 | BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 367955 | SEE H.10 | 50382903679558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |