BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
Report
- Report Number
- 1024879-2022-00537
- Event Type
- Malfunction
- Date Received
- September 16, 2022
- Date of Event
- September 1, 2022
- Report Date
- December 8, 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
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: 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: MEDICAL DEVICE LOT #: 1326307. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2021-11-22. MEDICAL DEVICE LOT #: 2091718. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2022-04-01. MEDICAL DEVICE LOT #: 1251309 MEDICAL DEVICE EXPIRATION DATE: 2023-03-31 DEVICE MANUFACTURE DATE: 2022-04-01. 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 ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES D9: RETURNED TO MANUFACTURER ON: 2022-09-14 H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FOR INVESTIGATION. THE CUSTOMER SAMPLES WERE EVALUATED ALONG WITH RETENTION SAMPLES OF THE INCIDENT LOT SELECTED FROM BD INVENTORY. THE SAMPLES WERE TESTED AND NO ISSUES RELATING TO 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 (ERRONEOUS RESULTS) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN/CUSTOMER AND CONTROL SAMPLES WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO 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.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS ERRONEOUS RESULTS. THIS EVENT OCCURRED 12 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS PRODUCT IS PROVIDING DISCREPANT RESULTS. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER REPORTS HAVING TO RUN THE SAME TUBES MULTIPLE TIMES OVER AND OVER TO OBTAIN BELIEVABLE RESULTS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS ERRONEOUS RESULTS. THIS EVENT OCCURRED 12 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THIS PRODUCT IS PROVIDING DISCREPANT RESULTS. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER REPORTS HAVING TO RUN THE SAME TUBES MULTIPLE TIMES OVER AND OVER TO OBTAIN "BELIEVABLE" RESULTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125239 | BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 367986 | SEE H.10 | 50382903679862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |