BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE
Report
- Report Number
- 1024879-2022-00407
- Event Type
- Malfunction
- Date Received
- August 1, 2022
- Date of Event
- July 26, 2022
- Report Date
- October 14, 2022
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679862
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2081974, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2022-03-22, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN, MEDICAL DEVICE LOT #: 2091714, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2022-04-01, MEDICAL DEVICE LOT #: 2089175, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2022-03-30. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTION INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE AND ERRONEOUS RESULTS. THE POOR BARRIER SEPARATION EVENT OCCURRED 3 TIMES. THE ERRONEOUS RESULTS EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "INCOMPLETE SEPARATION OF SERUM FROM CELLS ON PRODUCT 367986."
H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION AND ERRONEOUS RESULTS WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO POOR BARRIER SEPARATION AND ERRONEOUS RESULTS WERE OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, POOR BARRIER BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. ALL TUBES PERFORMED AS EXPECTED. THE LOT NUMBER OF THE ERRONEOUS RESULTS CONCERN WAS NOT AVAILABLE. IF THE INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE REOPENED AT THAT TIME. 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 POOR BARRIER SEPARATION AND ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO POOR BARRIER SEPARATION 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: IMDRF ANNEX A CODE: A0908 - INCORRECT, INADEQUATE OR IMPRECISE RESULT OR READINGS B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE AND ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "INCOMPLETE SEPARATION OF SERUM FROM CELLS ON PRODUCT 367986."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "INCOMPLETE SEPARATION OF SERUM FROM CELLS ON PRODUCT 367986."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE AND ERRONEOUS RESULTS. THE POOR BARRIER SEPARATION EVENT OCCURRED 3 TIMES. THE ERRONEOUS RESULTS EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "INCOMPLETE SEPARATION OF SERUM FROM CELLS ON PRODUCT 367986."
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTION INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE AND ERRONEOUS RESULTS. THE POOR BARRIER SEPARATION EVENT OCCURRED 3 TIMES. THE ERRONEOUS RESULTS EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "INCOMPLETE SEPARATION OF SERUM FROM CELLS ON PRODUCT 367986."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS POOR BARRIER SEPARATION OF SAMPLE AND ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "INCOMPLETE SEPARATION OF SERUM FROM CELLS ON PRODUCT 367986."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2287696 | BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 367986 | SEE H.10 | 50382903679862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |