BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
Report
- Report Number
- 1024879-2019-01267
- Event Type
- Malfunction
- Date Received
- July 26, 2019
- Date of Event
- April 26, 2019
- Report Date
- November 12, 2019
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679862
- PMA / PMN Number
- BK050036
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION RELATING TO LABEL LIFT THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH A CAPA TO IDENTIFY THE POTENTIAL ROOT CAUSE(S). CAPA 1064141. BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.
CORRECTION: DATE OF EVENT UPDATED AND AWARENESS DATE. THE FOLLOWING INFORMATION HAS BEEN UPDATED: DATE OF EVENT: 2019 (B)(6). DATE RECEIVED BY MANUFACTURER: 2019-05-06. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION RELATING TO LABEL LIFT THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.
IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAS BEEN FOUND EXPERIENCING LABEL LIFT OFF BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9018758 AND 9030860. -IT WAS REPORTED LABELS WERE LIFTING ON TUBES. PHONE CALL RECEIVED, - CUSTOMER WOULD LIKE TO REPORT LABELS LIFTING ON TUBES (LOT #9018758 AND 9030860). SHE HAS NO SPECIFIC DATE OF OCCURRENCE, NO SPECIFIC AMOUNT OF TUBES AFFECTED, NO SERIOUS INJURY, NO COURSE OF TREATMENT CHANGE, NO ERROEONUS RESULTS, NO EXPOSURE TO BODILY FLUIDS, NO MEDICAL INTERVENTION, NO SAMPLES AVAILABLE, NO PHOTOS WERE TAKEN NOR WILL BE TAKEN AND THIS WAS WITNESSED BEFORE USE.
IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAS BEEN FOUND EXPERIENCING LABEL LIFT OFF BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9018758 AND 9030860. IT WAS REPORTED LABELS WERE LIFTING ON TUBES. PHONE CALL RECEIVED, CUSTOMER WOULD LIKE TO REPORT LABELS LIFTING ON TUBES (LOT #9018758 AND 9030860). SHE HAS NO SPECIFIC DATE OF OCCURRENCE, NO SPECIFIC AMOUNT OF TUBES AFFECTED, NO SERIOUS INJURY, NO COURSE OF TREATMENT CHANGE, NO ERRONEOUS RESULTS, NO EXPOSURE TO BODILY FLUIDS, NO MEDICAL INTERVENTION, NO SAMPLES AVAILABLE, NO PHOTOS WERE TAKEN NOR WILL BE TAKEN AND THIS WAS WITNESSED BEFORE USE.
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 #: 9018758, MEDICAL DEVICE EXPIRATION DATE: 2020-01-31, DEVICE MANUFACTURE DATE: 2019-01-18. MEDICAL DEVICE LOT #: 9030860, MEDICAL DEVICE EXPIRATION DATE: 2020-01-31, DEVICE MANUFACTURE DATE: 2019-01-30. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT HAS BEEN REPORTED THAT THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAS BEEN FOUND EXPERIENCING LABEL LIFT OFF BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9018758 AND 9030860. IT WAS REPORTED LABELS WERE LIFTING ON TUBES. PHONE CALL RECEIVED, CUSTOMER WOULD LIKE TO REPORT LABELS LIFTING ON TUBES (LOT #9018758 AND 9030860). SHE HAS NO SPECIFIC DATE OF OCCURRENCE, NO SPECIFIC AMOUNT OF TUBES AFFECTED, NO SERIOUS INJURY, NO COURSE OF TREATMENT CHANGE, NO ERRONEOUS RESULTS, NO EXPOSURE TO BODILY FLUIDS, NO MEDICAL INTERVENTION, NO SAMPLES AVAILABLE, NO PHOTOS WERE TAKEN NOR WILL BE TAKEN AND THIS WAS WITNESSED BEFORE USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623819 | BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | SEE H.10 | 50382903679862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |