BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
Report
- Report Number
- 1024879-2022-00641
- Event Type
- Malfunction
- Date Received
- November 3, 2022
- Date of Event
- October 20, 2022
- Report Date
- January 10, 2023
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903678124
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS STOPPER CREEP OUT OR LOOSE CLOSURE AND SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES PRESENT VACUUM FAILURE." OBSERVATIONS: "A REVIEW OF THE SAMPLE COLLECTION PROCESS WAS CARRIED OUT IN THE PEDIATRIC UNITS WITH THE PERSONNEL THAT WAS AVAILABLE IN ACCOMPANIMENT WITH THE SPECIALIST, A SOCIALIZATION VIDEO WAS MADE TO BE DISSEMINATED IN THE DIFFERENT UNITS, WE DO NOT CONSIDER THAT THE FAILURES ARE ASSOCIATED WITH TUBE QUALITY PERFORMANCE, THEY ARE MORE ASSOCIATED WITH THE OPERATOR DUE TO THE USE OF OPEN TECHNIQUES IN PATIENTS WITH DIFFICULT VENOUS ACCESS, THE TUBES ARE NOT COVERED CORRECTLY, GENERATING AIR WHICH CAUSES THE TUBE TO BECOME UNCOVERED AND THE SAMPLE TO SPILL.¿ ANNEX A CODE: A 1503, A 050401.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL? YES D.10 RETURNED TO MANUFACTURER ON: 05-DEC-2022 H.6. INVESTIGATION SUMMARY: BD RECEIVED 5 SAMPLES AND 1 PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF WAS NOT OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 29 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY FUNCTIONAL TESTING AND UPON COMPLETION THE INDICATED FAILURE MODE FOR STOPPER POP OFF WAS OBSERVED ON THE RETENTION SAMPLES ONLY. 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 STOPPER POP OFF. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF STOPPER POP OFF THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. 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 H.10
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES PRESENT VACUUM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "VERBATIM: TUBES PRESENT VACUUM FAILURE ".
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS STOPPER CREEP OUT OR LOOSE CLOSURE AND SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES PRESENT VACUUM FAILURE." OBSERVATIONS: "A REVIEW OF THE SAMPLE COLLECTION PROCESS WAS CARRIED OUT IN THE PEDIATRIC UNITS WITH THE PERSONNEL THAT WAS AVAILABLE IN ACCOMPANIMENT WITH THE SPECIALIST, A SOCIALIZATION VIDEO WAS MADE TO BE DISSEMINATED IN THE DIFFERENT UNITS, WE DO NOT CONSIDER THAT THE FAILURES ARE ASSOCIATED WITH TUBE QUALITY PERFORMANCE, THEY ARE MORE ASSOCIATED WITH THE OPERATOR DUE TO THE USE OF OPEN TECHNIQUES IN PATIENTS WITH DIFFICULT VENOUS ACCESS, THE TUBES ARE NOT COVERED CORRECTLY, GENERATING AIR WHICH CAUSES THE TUBE TO BECOME UNCOVERED AND THE SAMPLE TO SPILL.¿
IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THERE WAS STOPPER CREEP OUT OR LOOSE CLOSURE AND SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES PRESENT VACUUM FAILURE." OBSERVATIONS: "A REVIEW OF THE SAMPLE COLLECTION PROCESS WAS CARRIED OUT IN THE PEDIATRIC UNITS WITH THE PERSONNEL THAT WAS AVAILABLE IN ACCOMPANIMENT WITH THE SPECIALIST, A SOCIALIZATION VIDEO WAS MADE TO BE DISSEMINATED IN THE DIFFERENT UNITS, WE DO NOT CONSIDER THAT THE FAILURES ARE ASSOCIATED WITH TUBE QUALITY PERFORMANCE, THEY ARE MORE ASSOCIATED WITH THE OPERATOR DUE TO THE USE OF OPEN TECHNIQUES IN PATIENTS WITH DIFFICULT VENOUS ACCESS, THE TUBES ARE NOT COVERED CORRECTLY, GENERATING AIR WHICH CAUSES THE TUBE TO BECOME UNCOVERED AND THE SAMPLE TO SPILL.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523082 | BD VACUTAINER® SERUM BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 367812 | 2125601 | 50382903678124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |