FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
MDR report key: 7081234
·
Received December 4, 2017
Report
- Report Number
- 1024879-2017-01131
- Event Type
- Malfunction
- Date Received
- December 4, 2017
- Date of Event
- September 30, 2016
- Report Date
- November 13, 2017
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903673426
- PMA / PMN Number
- K030573
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: (B)(4) CUSTOMER SAMPLES WERE SUBMERGED LEAK TESTED FOR CRACKED BARRELS AND LEAKAGE. NO LEAKAGE OR CRACKED BARRELS WERE IDENTIFIED IN THE INCIDENT SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6132861. CONCLUSION: BD IS UNABLE TO DUPLICATE THE REPORTED INCIDENT WITH EVALUATION OF THE CUSTOMER SAMPLES. HOWEVER, CAPA (B)(4) HAS BEEN INITIATED FOR FURTHER INVESTIGATION OF LEAKAGE IN TUBING AT THE NP END.
Description of Event or Problem · 1
IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET HAD CRACKS NEAR THE BARRELS RESULTING IN BLOOD LEAKAGE. NO INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 858149 | BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET | BLOOD COLLECTION SET | JKA | BECTON, DICKINSON & CO., (BD) | 6132861 | 50382903673426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |