FDA Adverse Event
Malfunction
Summary report: N
81-082416 OEM FOLEY CATH.16FR 400 MALE
MDR report key: 309494
·
Received December 19, 2000
Report
- Report Number
- 1046367-2000-00032
- Event Type
- Malfunction
- Date Received
- December 19, 2000
- Date of Event
- November 9, 2000
- Report Date
- December 15, 2000
- Manufacturer
- DEROYAL
- Product Code
- KOD
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING OPEN HEART SURGERY THE PT SUFFERED FROM URINARY RETENTION DUE TO AN OCCLUSION IN THE FOLEY CATHETER. INTERVENTIONS INCLUDED REPLACEMENT OF A NEW CATHETER AND A DIURETIC TO RELIEVE THE DISCOMFORT ASSOCIATED WITH THE DISTENDED BLADDER. BLOCKED CATHETER DESTROYED BY CUSTOMER DUE TO CONTAMINATION. THE SAME TYPE OF INCIDENT OCCURRED DURING THREE DIFFERENT PROCEDURES. ADDITIONAL REPORTS 00031 AND 00033 ATTACHED. INFORMATION REGARDING THIS COMPLAINT HAS BEEN FORWARDED TO THE OUTSIDE VENDOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 81-082416 OEM FOLEY CATH.16FR 400 MALE | 7R7 FOLEY CATHETER | KOD | DEROYAL | IR | 203179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |