BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
Report
- Report Number
- 1024879-2022-00270
- Event Type
- Malfunction
- Date Received
- May 16, 2022
- Date of Event
- May 6, 2022
- Report Date
- June 20, 2022
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 00382903679881
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
ADDITIONAL INFORMATION HAS BEEN PROVIDED. ADDITIONAL LOT NUMBERS WERE RECEIVED UPDATING THE PREVIOUS MDR SUBMISSION. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1312507. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. H.4. DEVICE MANUFACTURE DATE: 2021-11-08. D.4. MEDICAL DEVICE LOT #: 1326277. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. H.4. DEVICE MANUFACTURE DATE: 2021-11-22 D.4. MEDICAL DEVICE LOT #: 1333110. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. H.4. DEVICE MANUFACTURE DATE: 2021-11-29 D.4. MEDICAL DEVICE LOT #: 2039096. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. H.4. DEVICE MANUFACTURE DATE: 2022-02-08. D.4. MEDICAL DEVICE LOT #: 2031111. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31. H.4. DEVICE MANUFACTURE DATE: 2022-01-31. D.4. MEDICAL DEVICE LOT #:1326291. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. H.4. DEVICE MANUFACTURE DATE: 2021-11-22. D.4. MEDICAL DEVICE LOT #: 1340600. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. H.4. DEVICE MANUFACTURE DATE: 2021-12-06. D.4. MEDICAL DEVICE LOT #: 1305657. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-10-31. H.4. DEVICE MANUFACTURE DATE: 2021-11-01. D.4. MEDICAL DEVICE LOT #: 1340598. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. H.4. DEVICE MANUFACTURE DATE: 2021-12-06.
H6: INVESTIGATION SUMMARY : BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THE CUSTOMER HAS ACKNOWLEDGED AN ISSUE WITH SAMPLE INTEGRITY (EXCESSIVE EVAPORATION) TO BE THE CAUSE OF THEIR REPORTED DEFECT (ERRONEOUS RESULTS) AFTER CONSULTATION WITH BD'S TECHNICAL SERVICE TEAM. 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 ERRONEOUS RESULTS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES WERE EXPERIENCING ERRONEOUS RESULTS. CUSTOMER PROBLEM: SM 367988 - DISCREPANT RESULTS. DISCREPANT RESULTS : DOES NOT MATCH CLINICAL CONDITION.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES WERE EXPERIENCING ERRONEOUS RESULTS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES WERE EXPERIENCING ERRONEOUS RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2030821 | BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | SEE H.10. | 00382903679881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |