BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR
Report
- Report Number
- 3003916417-2022-00198
- Event Type
- Malfunction
- Date Received
- September 20, 2022
- Date of Event
- November 29, 2022
- Report Date
- January 21, 2023
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- JKA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 2181400 D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30 H.4. DEVICE MANUFACTURE DATE: 2022-07-14 D.4. MEDICAL DEVICE LOT #: 2181401 D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30 H.4. DEVICE MANUFACTURE DATE: 2022-07-21.
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.
H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT FIVE [5] PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF WITH THE INCIDENT LOTS WAS NOT OBSERVED. THE PHOTOS SHOW THE CAPS IN A TRAY WITHOUT THE TUBE. IT IS NOT POSSIBLE TO EVALUATE HOW THE STOPPERS WERE REMOVED WITH THE INFORMATION PROVIDED OR EVALUATE A MANUFACTURING DEFECT. ADDITIONALLY, TWO HUNDRED [200] RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO STOPPER POP OFF AS ALL SAMPLES MET SPECIFICATIONS. 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 STOPPER POP OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-11-14. H.6. INVESTIGATION SUMMARY: BD RECEIVED NINE (9) CUSTOMER RETURNED SAMPLES FROM BATCH 2181401 AND FIVE (5) CUSTOMER PHOTOS. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF WITH THE INCIDENT LOTS WAS NOT OBSERVED. THE PHOTOS SHOW THE CAPS IN A TRAY WITHOUT THE TUBE. IT IS NOT POSSIBLE TO EVALUATE HOW THE STOPPERS WERE REMOVED WITH THE INFORMATION PROVIDED OR EVALUATE A MANUFACTURING DEFECT. THE RETURNED SAMPLES WERE TESTED AND 3 OF THE TUBES PRESENTED STOPPER CREEP OUT BUT THE STOPPER DID NOT POP OFF. ADDITIONALLY, TWO HUNDRED [200] RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO STOPPER POP OFF AS ALL SAMPLES MET SPECIFICATIONS. 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 ABLE TO BE CONFIRMED FOR STOPPER CREEP OUT, BUT UNABLE TO BE CONFIRMED FOR STOPPER POP OFF.
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPPED OUT OF THE TUBE. THIS EVENT OCCURRED 35 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "STOPPERS ARE POPPING OFF. HAPPENING IN TRANSPORT AND HANDLING (BEFORE CENTRIFUGATION) AND ALSO AFTER CENTRIFUGATION."
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPPED OUT OF THE TUBE. THIS EVENT OCCURRED 35 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "STOPPERS ARE POPPING OFF. HAPPENING IN TRANSPORT AND HANDLING (BEFORE CENTRIFUGATION) AND ALSO AFTER CENTRIFUGATION."
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPPED OUT OF THE TUBE. THIS EVENT OCCURRED 35 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "STOPPERS ARE POPPING OFF. HAPPENING IN TRANSPORT AND HANDLING (BEFORE CENTRIFUGATION) AND ALSO AFTER CENTRIFUGATION."
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPPED OUT OF THE TUBE. THIS EVENT OCCURRED 35 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "STOPPERS ARE POPPING OFF. HAPPENING IN TRANSPORT AND HANDLING (BEFORE CENTRIFUGATION) AND ALSO AFTER CENTRIFUGATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2635462 | BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON DICKINSON IND. CIRURGICAS LTDA | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |