FDA Adverse Event
Malfunction
Summary report: N
RUSCH FOLEY CATHETER, 3-WAY 30CC 24 FR
MDR report key: 1931620
·
Received November 22, 2010
Report
- Report Number
- 8040412-2010-00098
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Report Date
- October 27, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- EZL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CATHETER WAS FOUND DEFLATED IN THE PT'S BED. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH FOLEY CATHETER, 3-WAY 30CC 24 FR | FOLEY CATHETER | EZL | TELEFLEX MEDICAL | NA | 09GE27 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |