FDA Adverse Event
Malfunction
Summary report: N
SPINCHRON
MDR report key: 47915
·
Received September 20, 1996
Report
- Report Number
- 2912312-1996-00002
- Event Type
- Malfunction
- Date Received
- September 20, 1996
- Date of Event
- April 15, 1996
- Report Date
- September 16, 1996
- Manufacturer
- BECKMAN INSTRUMENTS, INC.
- Product Code
- JQC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Description of Event or Problem · 1
A CANISTER IN A CENTRIFUGE BUCKET BROKE, DAMAGING THE ROTOR, LID GASKET AND DENTING THE CENTRIFUGE LID. SPECIMENS AND BROKEN TUBE PIECES WERE EXPELLED FROM THE SPACE BETWEEN THE LID AND THE CENTRIFUGE BODY. NO INJURIES WERE ATTRIBUTED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINCHRON | CENTRIFUGE | JQC | BECKMAN INSTRUMENTS, INC. | SPINCHRON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |