D
Patient 1
DURING A CYSTOSCOPY, THE TIP OF THE FOLEY CATHETER WAS FOUND IN THE BLADDER.
MAUDE MDR 3232261
- MDR report key
- 3232261
- Report number
- 1417592-2013-00058
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-05-30
- Date received
- 2013-07-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JULIE FINLEY
- Address
- ONE MEDLINE PLACE MUNDELEIN IL 60060 US
- Phone
- 847-847-8476
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FOLEY CATHETER, 16F | MEDLINE INDUSTRIES, INC. | NWR | DYND160816S | 12LB7632 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-07-09 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
IT WAS REPORTED THAT THE CATHETER WAS REMOVED DURING A SURGICAL PROCEDURE IN ORDER TO INSERT A CYSTOSCOPE. DURING THE CYSTOSCOPY, A FOREIGN OBJECT WAS VISUALIZED IN THE BLADDER AND WAS DETERMINED TO BE THE TIP OF THE FOLEY CATHETER. THE SAMPLE WAS NOT RETURNED FOR EVAL BUT WAS DESCRIBED AS MEASURING ABOUT 3-4 INCHES IN LENGTH. THE RISK MANAGER DID NOT KNOW WHAT PROCEDURE WAS BEING PERFORMED OR IF ANY SURGICAL INSTRUMENTS COULD HAVE POSSIBLY DAMAGED THE INTEGRITY OF THE CATHETER. WE HAVE NOT HAD A SIMILAR INCIDENT REPORTED TO US FOR THIS CATHETER. A ROOT CAUSE HAS NOT BEEN DETERMINED.