FDA Adverse Event
Malfunction
Summary report: N
RUSCH FOLEY CATHETERS, 2-WAY PEDIATRIC, 8FR
MDR report key: 2142125
·
Received May 26, 2011
Report
- Report Number
- 8040412-2011-00078
- Event Type
- Malfunction
- Date Received
- May 26, 2011
- Date of Event
- February 23, 2011
- Report Date
- May 6, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- KOD
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS AVAILABLE FOR THE MANUFACTURER TO EVALUATE. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGED: AFTER THE CATHETER INSERTION, THE STYLET BROKE DURING THE REMOVAL. THE CATHETER WAS REMOVED AND A NEW ONE WAS SUCCESSFULLY INSERTED. NO PART REMAINED INSIDE THE PATIENT. THE PATIENT CURRENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH FOLEY CATHETERS, 2-WAY PEDIATRIC, 8FR | FOLEY CATHETER | KOD | TELEFLEX MEDICAL | NA | 10DE14 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |