BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
Report
- Report Number
- 1024879-2022-00736
- Event Type
- Malfunction
- Date Received
- December 21, 2022
- Date of Event
- November 28, 2022
- Report Date
- April 20, 2023
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679886
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT #: 2181522. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. H.4. DEVICE MANUFACTURE DATE: 2022-06-30.
H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR FIBRIN WAS OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AS ALL TUBES EXHIBITED PROPER FILL. BD WAS ABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODE, FIBRIN, BECAUSE THE DEFECT WAS PRESENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. VISUAL OBSERVATIONS OF FIBRIN STRANDS WERE SEEN BUT VISUAL OBSERVATIONS OF FIBRIN MASS WERE NOT SEEN WITH RESPECT TO BOTH RETAIN AND CONTROL SAMPLES TESTED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE FIBRIN (FIBRIN STRANDS). BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
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.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS A CLOGGED /BLOCKED INSTRUMENTATION PROBE AND MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FIBRIN FROM TUBES IS CLOGGING THEIR NEW ROCHE INSTRUMENT." THERE WAS NO REPORT OF ERRONEOUS RESULTS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS A CLOGGED /BLOCKED INSTRUMENTATION PROBE AND MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FIBRIN FROM TUBES IS CLOGGING THEIR NEW ROCHE INSTRUMENT." THERE WAS NO REPORT OF ERRONEOUS RESULTS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS A CLOGGED /BLOCKED INSTRUMENTATION PROBE AND MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FIBRIN FROM TUBES IS CLOGGING THEIR NEW ROCHE INSTRUMENT." THERE WAS NO REPORT OF ERRONEOUS RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1630639 | BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 367988 | 2181522 | 50382903679886 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |