FDA Adverse Event
Malfunction
Summary report: N
VENOJECT II SODIUM FLUORIDE TUBE
MDR report key: 36956
·
Received September 6, 1996
Report
- Report Number
- MW1009890
- Event Type
- Malfunction
- Date Received
- September 6, 1996
- Manufacturer
- TERUMO MEDICAL CORP.
- Product Code
- JKA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Description of Event or Problem · 1
RPTR RECEIVED 2 BOXES OF SODIUM FLUORIDE TUBES. THE BOXES WERE UNDAMAGED, BUT UPON OPENING IT WAS DISCOVERED THAT MOST OF THE TUBES WERE FLATTENED OR COLLAPSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENOJECT II SODIUM FLUORIDE TUBE | BLOOD COLLECITON TUBE 5ML | JKA | TERUMO MEDICAL CORP. | * | TL0741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |