FDA Adverse Event
Malfunction
Summary report: N
RUSCH FOLEY CATHETER, 2-WAY/PED, 3CC, 8FR
MDR report key: 2142103
·
Received May 26, 2011
Report
- Report Number
- 8040412-2011-00081
- Event Type
- Malfunction
- Date Received
- May 26, 2011
- Report Date
- May 16, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- EZL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: PER FRANCE AFFILIATE: THE CATHETER SPLIT IN TWO WHEN SLIDING THE NAPPY UNDER THE BABY EVEN IF THERE WAS A SECURITY BUCKLE AND NO FORCE WAS APPLIED. ANOTHER CATHETER WAS SUCCESSFULLY USED. PT CURRENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RUSCH FOLEY CATHETER, 2-WAY/PED, 3CC, 8FR | FOLEY CATHETER | EZL | TELEFLEX MEDICAL | NA | 11AE05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |