FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® GLASS SERUM TUBE
MDR report key: 7077208
·
Received December 1, 2017
Report
- Report Number
- 1917413-2017-00388
- Event Type
- Malfunction
- Date Received
- December 1, 2017
- Date of Event
- August 14, 2016
- Report Date
- November 6, 2017
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JKA
- PMA / PMN Number
- PREAMENDMENT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. PHOTOS OF THE CUSTOMER SAMPLE SHOWS EVIDENCE OF A CRACKED TUBE BY WHICH BLOOD LEAKAGE COULD OCCUR. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6040919. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BD VACUTAINER® GLASS SERUM TUBE LEAKED BLOOD FROM A CRACK DURING USE. NO INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 853210 | BD VACUTAINER® GLASS SERUM TUBE | BLOOD COLLECTION TUBE | JKA | BECTON, DICKINSON & CO. | 6040919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |