FDA Adverse Event
Malfunction
Summary report: N
RUSCH 100% SILICONE 2 WAY 3CC 8 FR
MDR report key: 3070313
·
Received April 17, 2013
Report
- Report Number
- 8040412-2013-00068
- Event Type
- Malfunction
- Date Received
- April 17, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 25, 2013
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE DEVICE IS AVAILABLE FOR INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: PT HAD A STRAIGHT CATHETER PLACED ON PEDIATRIC OUTPATIENT. PT WENT DOWN TO DIAGNOSTIC IMAGING. THE STAFF IN DI WENT TO DO PROCEDURE AND NOTICED THE CATHETER WAS BROKEN, ONE PART IN PT, ONE PART STILL ATTACHED TO THE LEG WITH A CATHETER SECURE. PROCEDURE STILL OCCURRED, NO HARM OT PT. CATHETER REMOVED WITH NO DIFFICULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166303 | RUSCH 100% SILICONE 2 WAY 3CC 8 FR | FOLEY CATHETER | KOD | TELEFLEX MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |