BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR
Report
- Report Number
- 3003916417-2022-00141
- Event Type
- Malfunction
- Date Received
- August 5, 2022
- Date of Event
- July 7, 2022
- Report Date
- November 1, 2022
- 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
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 #: 2120754. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2022-05-27. MEDICAL DEVICE LOT #: 2120753. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2022-05-27. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT THREE (3) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES FOR STOPPER POP OFF IN CENTRIFUGE OR DECAPPING WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, TWO HUNDRED (200) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED THAT WOULD RELATE TO STOPPER POP OFF IN CENTRIFUGE 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 MODES OF STOPPER POP OFF IN CENTRIFUGE OR DECAPPING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.
H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT THREE (3) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES FOR STOPPER POP OFF IN CENTRIFUGE OR DECAPPING WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, TWO HUNDRED (200) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED THAT WOULD RELATE TO STOPPER POP OFF IN CENTRIFUGE 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 MODES OF STOPPER POP OFF IN CENTRIFUGE OR DECAPPING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPPED OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "THE TUBES' CAPS ARE OPENING AFTER CENTRIFUGATION, EVEN WHEN SAMPLE DRAW IS MADE THROUGH VACUUM."
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPPED OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "THE TUBES' CAPS ARE OPENING AFTER CENTRIFUGATION, EVEN WHEN SAMPLE DRAW IS MADE THROUGH VACUUM."
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPPED OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "THE TUBES' CAPS ARE OPENING AFTER CENTRIFUGATION, EVEN WHEN SAMPLE DRAW IS MADE THROUGH VACUUM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2433025 | 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 |