BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR
Report
- Report Number
- 3003916417-2022-00093
- Event Type
- Malfunction
- Date Received
- June 21, 2022
- Date of Event
- May 20, 2022
- Report Date
- October 18, 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
THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR THERE WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THIS BATCH HAS RESULTED IN FIBRIN FORMATION IN MOST OF THE UNITS." CUSTOMER HAS NOT CHANGED PROCESSES RELATED TO SAMPLE DRAW, HOMOGENIZATION, OR TIME FOR CLOTTING. CUSTOMER REPORTS DELAY TO DELIVER EXAMS RESULTS AND HAS SEPARATED PART OF THE BATCH TO PREVENT ANY DAMAGE TO ITS EQUIPMENT.
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 RECEIVED CUSTOMER SAMPLES, AND 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR FIBRIN WAS NOT OBSERVED. ADDITIONALLY, CUSTOMER RETURNS AND RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO FIBRIN WERE OBSERVED. 200 RETENTION SAMPLES WERE VISUALLY EVALUATED AND ALL SAMPLES PRESENTED THE ADDITIVE INSIDE THE TUBE. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, FIBRIN BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF CUSTOMER RETURNS, RETAIN, AND CONTROL SAMPLES, TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. ALL TUBES PERFORMED AS EXPECTED. 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 FIBRIN. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO FIBRIN WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE.
H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR FIBRIN WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO FIBRIN WERE OBSERVED. 200 SAMPLES WERE VISUALLY EVALUATED AND ALL SAMPLES PRESENTED THE ADDITIVE INSIDE THE TUBE. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, FIBRIN BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. ALL TUBES PERFORMED AS EXPECTED. 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 FIBRIN. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO FIBRIN WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR THERE WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THIS BATCH HAS RESULTED IN FIBRIN FORMATION IN MOST OF THE UNITS." CUSTOMER HAS NOT CHANGED PROCESSES RELATED TO SAMPLE DRAW, HOMOGENIZATION, OR TIME FOR CLOTTING. CUSTOMER REPORTS DELAY TO DELIVER EXAMS RESULTS AND HAS SEPARATED PART OF THE BATCH TO PREVENT ANY DAMAGE TO ITS EQUIPMENT.
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR THERE WAS MISSING ADDITIVE, RED CELL HANG UP AND HEMOLYSIS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS BATCH HAS RESULTED IN FIBRIN FORMATION IN MOST OF THE UNITS. CUSTOMER HAS NOT CHANGED PROCESSES RELATED TO SAMPLE DRAW, HOMOGENIZATION, TIME FOR CLOTTING EITHER. CUSTOMER REPORTS DELAY TO DELIVER EXAMS RESULTS AND HAS SEPARATED PART OF THE BATCH TO PREVENT ANY DAMAGE TO ITS EQUIPMENT. ALTHOUGH THE CUSTOMER REPORTS ONLY THE FIBRIN, IN PICTURE PROVIDED SPECIFIC FOR THE PATIENT BORN ON (B)(6) 2001 WITH SICKLE CELL DISORDERS, IT'S POSSIBLE TO OBSERVE HEMOLYSIS AND RED CELL HANG UP ISSUES.
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR THERE WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THIS BATCH HAS RESULTED IN FIBRIN FORMATION IN MOST OF THE UNITS." CUSTOMER HAS NOT CHANGED PROCESSES RELATED TO SAMPLE DRAW, HOMOGENIZATION, OR TIME FOR CLOTTING. CUSTOMER REPORTS DELAY TO DELIVER EXAMS RESULTS AND HAS SEPARATED PART OF THE BATCH TO PREVENT ANY DAMAGE TO ITS EQUIPMENT.
IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR THERE WAS MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THIS BATCH HAS RESULTED IN FIBRIN FORMATION IN MOST OF THE UNITS." CUSTOMER HAS NOT CHANGED PROCESSES RELATED TO SAMPLE DRAW, HOMOGENIZATION, OR TIME FOR CLOTTING. CUSTOMER REPORTS DELAY TO DELIVER EXAMS RESULTS AND HAS SEPARATED PART OF THE BATCH TO PREVENT ANY DAMAGE TO ITS EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1965324 | BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON DICKINSON IND. CIRURGICAS LTDA | 1357782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Unknown |