FDA Adverse Event
Malfunction
Summary report: N
ECONOMY BONE MARROW BIOPSY AND ASPIRATION TRAY
MDR report key: 78159
·
Received March 24, 1997
Report
- Report Number
- 1423537-1997-00055
- Event Type
- Malfunction
- Date Received
- March 24, 1997
- Report Date
- March 24, 1997
- Manufacturer
- ALLEGIANCE-SURGICAL GRP.
- Product Code
- KNW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ACCOUNT REPORTED THAT THE NEEDLE IN THE BEK4511 TRAY IS BENDING INWARD UPON INSERTION IN TO THE BONE, MAKING IT DIFFICULT TO REMOVE THE SAMPLE AND THEY HAVE HAD TO RESTICK THE PT FOR BIOPSY SAMPLE. THE STAFF IS CURRENTLY USING THE CJ4511X SINGLE STERILE NEEDLE FOR THE PROCEDURE. THE CJ4511X NEEDLE DOES NOT BEND UPON INSERTION INTO THE BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECONOMY BONE MARROW BIOPSY AND ASPIRATION TRAY | BONE BIOPSY TRAY | KNW | ALLEGIANCE-SURGICAL GRP. | BEK4511 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |