BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
Report
- Report Number
- 1024879-2023-00867
- Event Type
- Malfunction
- Date Received
- December 4, 2023
- Date of Event
- November 1, 2023
- Report Date
- April 12, 2024
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679886
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3126859 D4. MEDICAL DEVICE EXPIRATION DATE: 04/30/2024 H4. DEVICE MANUFACTURE DATE: 05/06/2023 THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3145889 D4. MEDICAL DEVICE EXPIRATION DATE: 05/31/2024 H4. DEVICE MANUFACTURE DATE: 05/25/2023 THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3153059 D4. MEDICAL DEVICE EXPIRATION DATE: 05/31/2024 H4. DEVICE MANUFACTURE DATE: 06/02/2023 THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3153060 D4. MEDICAL DEVICE EXPIRATION DATE: 05/31/2024 H4. DEVICE MANUFACTURE DATE: 06/02/2023 THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: UNKNOWN D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING INFORMATION HAS BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: ADDITIONAL TESTING WAS PERFORMED FOR THE INVESTIGATION. H.6. INVESTIGATION SUMMARY: BD RECEIVED TWENTY THREE (23) SAMPLES AND TWENTY TWO (22) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER, ADDITIVE ABNORMALITY, AND DOUBLE LABEL WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER, ADDITIVE ABNORMALITY, AND DOUBLE LABEL WITH THE INCIDENT LOT WAS OBSERVED. BATCH# 3145843, 2 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR FM. 1 OF 2 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM FM BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3145843, 2 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR ADDITIVE ABNORMALITY. 1 OF 2 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM ADDITIVE ABNORMALITY BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3126859, 5 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR FM. 1 OF 5 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM FM BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3126859, 5 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR ADDITIVE ABNORMALITY. 4 OF 5 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM ADDITIVE ABNORMALITY BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3116891, 4 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR FM. 4 OF 4 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM FM BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3145889, 8 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR FM. 4 OF 8 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM FM BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3145889, 8 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR ADDITIVE ABNORMALITY. 2 OF 8 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM ADDITIVE ABNORMALITY BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3153060, 2 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR FM. 1 OF 2 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM FM BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3116892, 4 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR FM. 4 OF 4 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM FM BASED ON CUSTOMER SAMPLE ANALYSIS. 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 FOREIGN MATTER, ADDITIVE ABNORMALITY, AND DOUBLE LABEL. 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. ADDITIONAL TESTING WAS PERFORMED: SAMPLES FROM EACH BATCH WERE INVESTIGATED TO DETERMINE THE UNIDENTIFIED FOREIGN MATTER IN THE BOTTOM OF THE TUBE AND THE FOLLOWING RESULTS WERE FOUND, THE UNIDENTIFIED MATTER IN THE SAMPLES FROM LOTS 3116891 AND 3145843 WERE CONSISTENT WITH CLOT ACTIVATOR ADDITIVE MATERIAL. THE SAMPLE FROM LOT 3145889 MICROSCOPICALLY APPEARS CONSISTENT WITH CLOT ACTIVATOR ADDITIVE MATERIAL BUT FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS INCONCLUSIVE. SCANNING ELECTRON MICROSCOPE (SEM-EDS) CONFIRMS PRESENCE OF SILICA CONSISTENT WITH CLOT ACTIVATOR ADDITIVE IN SAMPLES FROM LOT 3116892. BASED ON A REVIEW OF BATCH RECORDS AND THE INVESTIGATION RESULTS, NO DEFINITIVE ROOT CAUSE FROM THE MANUFACTURING PROCESS HAS BEEN IDENTIFIED AS A CONTRIBUTOR TO THE CUSTOMERS REPORTED DEFECTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR MONITORING OF CURRENT TRENDS.
THE FOLLOWING FIELDS WERE UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B5. IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, TUBES WERE FOUND WITH ADDITIVE ABNORMALITIES AND ARTIFACTS IN TUBES. NO PATIENT IMPACT. TUBES WITH ADDITIVE ABNORMALITY: LOT 3126859, QTY 23. LOT 3145889, QTY 7. TUBES WITH FOREIGN MATTER: LOT 3126859, QTY 1. LOT 3145843, QTY 1. LOT 3145889, QTY 57. LOT 3153060, QTY 2. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 16-FEB-2024. D4. MEDICAL DEVICE LOT #: CORRECTION - PREVIOUSLY REPORTED UNKNOWN LOT AND LOT 3153059 WERE INCLUDED IN ERROR. COMPLETE LIST OF AFFECTED LOTS: D4. MEDICAL DEVICE LOT#: 3126859. D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2024. H4. DEVICE MANUFACTURE DATE: 06-MAY-2023. D4. MEDICAL DEVICE LOT#: 3145843. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. H4. DEVICE MANUFACTURE DATE: 25-MAY-2023. D4. MEDICAL DEVICE LOT#: 3145889. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. H4. DEVICE MANUFACTURE DATE: 25-MAY-2023. D4. MEDICAL DEVICE LOT#: 3153060. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. H4. DEVICE MANUFACTURE DATE: 02-JUN-2023. H6. INVESTIGATION SUMMARY: BD RECEIVED SEVENTEEN (17) SAMPLES AND TWENTY-TWO (22) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODES FOR FOREIGN MATTER AND ADDITIVE ABNORMALITY WERE OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODES FOR FOREIGN MATTER AND ADDITIVE ABNORMALITY WERE OBSERVED. BATCH# 3145843, 2 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR FM. 1 OF 2 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM FM BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3145843, 2 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR ADDITIVE ABNORMALITY. 1 OF 2 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM ADDITIVE ABNORMALITY BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3126859, 5 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR FM. 1 OF 5 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM FM BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3126859, 5 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR ADDITIVE ABNORMALITY. 4 OF 5 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM ADDITIVE ABNORMALITY BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3145889, 8 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR FM. 4 OF 8 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM FM BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3145889, 8 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR ADDITIVE ABNORMALITY. 2 OF 8 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM ADDITIVE ABNORMALITY BASED ON CUSTOMER SAMPLE ANALYSIS. BATCH# 3153060, 2 CUSTOMER SAMPLES WAS SUBJECTED TO A VISUAL INSPECTION FOR FM. 1 OF 2 SAMPLES FAILED. THEREFORE, BD IS ABLE TO CONFIRM FM BASED ON CUSTOMER SAMPLE ANALYSIS. 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 MODES FOREIGN MATTER AND ADDITIVE ABNORMALITY. 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. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, TUBES WERE FOUND WITH ADDITIVE ABNORMALITIES AND ARTIFACTS IN TUBES. NO PATIENT IMPACT.
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, TUBES WERE FOUND WITH ADDITIVE ABNORMALITIES AND ARTIFACTS IN TUBES. NO PATIENT IMPACT. TUBES WITH ADDITIVE ABNORMALITY: LOT 3126859, QTY (B)(4); LOT 3145889, QTY (B)(4). TUBES WITH FOREIGN MATTER: LOT 3126859, QTY (B)(4); LOT 3145843, QTY (B)(4); LOT 3145889, QTY (B)(4); LOT 3153060, QTY (B)(4).
IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, TUBES WERE FOUND WITH ADDITIVE ABNORMALITIES AND ARTIFACTS IN TUBES. NO PATIENT IMPACT. TUBES WITH ADDITIVE ABNORMALITY: LOT 3126859, QTY 23. LOT 3145889, QTY 7. TUBES WITH FOREIGN MATTER: LOT 3126859, QTY 1. LOT 3145843, QTY 1. LOT 3145889, QTY 57. LOT 3153060, QTY 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2177369 | BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | SEE H10 | 50382903679886 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |