FDA Adverse Event
Injury
Summary report: N
A TRAUM AXIOM ANGLE SILICONE CATHETER
MDR report key: 10818
·
Received December 13, 1993
Report
- Report Number
- 10818
- Event Type
- Injury
- Date Received
- December 13, 1993
- Date of Event
- September 30, 1993
- Report Date
- October 18, 1993
- Manufacturer
- AXIOM MEDICAL, INC.
- Product Code
- KDQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
RN WAS REMOVING CHEST TUBE AFTER SURGERY. TUBE BROKE OFF AND APPROX 9 CM REMAINED IN CHEST. PIECE HAD TO BE REMOVED SURGICALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | A TRAUM AXIOM ANGLE SILICONE CATHETER | CHEST TUBE | KDQ | AXIOM MEDICAL, INC. | 28 FRENCH SIX EYES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |