FDA Adverse Event
Injury
Summary report: N
SPEEDICATH CH14 MALE
MDR report key: 1933092
·
Received December 20, 2010
Report
- Report Number
- 3006606901-2010-00011
- Event Type
- Injury
- Date Received
- December 20, 2010
- Report Date
- November 23, 2010
- Manufacturer
- COLOPLAST A/S
- Product Code
- GBM
- PMA / PMN Number
- K023254
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
TESTING OF THE SPEEDICATH CH14 MALE CATHETERS RETURNED DID NOT PROVIDE US WITH AN EXPLANATION AS TO THE CAUSE OF THE INCIDENT REPORTED. FIVE CATHETERS WERE EVALUATED USING A FRICTION TEST. ALL VALUES WERE WITHIN THE ACCEPTABLE VALUES IN THE PRODUCT SPECIFICATION. A RECHECK OF THE PRODUCT DOCUMENTATION FOR THIS LOT NUMBER DID NOT REVEAL ANY NORM DEVIATION THAT COULD BE RELATED TO THE COMPLAINT.
Description of Event or Problem · 1
(B)(4). ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A CATHETER WITH FRICTION/COATING PROBLEMS. THE CATHETER IS STIFF; THE CUSTOMER GOT BLEEDING FROM THE CATHETER. THE CATHETER IS REPORTED TO BE ROUGH (RUGGED) WHEN YOU TOUCH THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPEEDICATH CH14 MALE | INTERMITTENT CATHETER | GBM | COLOPLAST A/S | 2841401030 | 2485484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |