FDA Adverse Event
Malfunction
Summary report: N
VACUTAINER® PLUS PLASTIC SST¿ BLOOD COLLECTION TUBES
MDR report key: 7098167
·
Received December 7, 2017
Report
- Report Number
- 1710034-2017-00911
- Event Type
- Malfunction
- Date Received
- December 7, 2017
- Date of Event
- October 5, 2016
- Report Date
- November 21, 2017
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 50382903679893
- PMA / PMN Number
- K023075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. RETURNED CUSTOMER PHOTO SHOWED MISSING/DAMAGE OCCURRING ON THE HEMOGARD SHIELD. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7012802. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE, 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE, HAD A HEMOGARD CAP WHICH WAS SHORT. NO MEDICAL INTERVENTION OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 875230 | VACUTAINER® PLUS PLASTIC SST¿ BLOOD COLLECTION TUBES | BLOOD COLLECTION SET | JKA | BECTON, DICKINSON & CO., (BD) | 6092878 | 50382903679893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |