FDA Adverse Event
Malfunction
Summary report: N
CIRCLE "C" DUAL LUMEN CATHETER KIT
MDR report key: 213820
·
Received March 10, 1999
Report
- Report Number
- 1056436-1999-00035
- Event Type
- Malfunction
- Date Received
- March 10, 1999
- Report Date
- February 9, 1999
- Manufacturer
- NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MED PRODUCTS INC.
- Product Code
- KOC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 02/09/1999, THE MFR REC'D A FAX FROM THE INTERNATIONAL DISTRIBUTOR THAT STATES THE FOLLOWING: DURING INSERTION, THE GUIDEWIRE KINKS AND MAKES IT IMPOSSIBLE TO CONTINUE THE INSERTION. ADDITIONALLY, IT WAS VERY DIFFICULT TO REMOVE THE GUIDEWIRE. THIS HAPPENS IN ABOUT 20% OF THE USED CATHETERS. ON 03/05/1999, THE MFR'S INTERNATIONAL REPRESENTATIVE INFORMED THE MFR THAT THE DEVICE WAS NOT AVAILABLE TO BE RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIRCLE "C" DUAL LUMEN CATHETER KIT | ACUTE POLYURETHANE CATHETER | KOC | NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MED PRODUCTS INC. | NA | SE97317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |