FDA Adverse Event
Malfunction
Summary report: N
BAUMGARTEN WIRE TWISTER
MDR report key: 758336
·
Received October 21, 2005
Report
- Report Number
- 2515651-2005-00009
- Event Type
- Malfunction
- Date Received
- October 21, 2005
- Date of Event
- September 23, 2005
- Report Date
- October 21, 2005
- Manufacturer
- PILLING SURGICAL
- Product Code
- HXS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS BEING EVALUATED BY THE MANUFACTURING FACILITY. A FOLLOW UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PIECE OF THE INSERT FROM THE BAUMGARTEN WIRE (CATALOG #142521) BROKE AND FELL INTO THE PATIENTS CHEST. THE BROKEN PIECE WAS RECOVERED FROM THE PATIENT AND THERE WAS NO PATIENT INJURY AIR ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAUMGARTEN WIRE TWISTER | WIRE TWISTER FORCEP | HXS | PILLING SURGICAL | NA | UU4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |