FDA Adverse Event
Malfunction
Summary report: N
CIRCLE "C" DUAL LUMEN CATHETER KIT
MDR report key: 441324
·
Received February 4, 2003
Report
- Report Number
- 1056436-2003-00008
- Event Type
- Malfunction
- Date Received
- February 4, 2003
- Report Date
- February 4, 2003
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- KOC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 01/14/2003, THE INTERNATIONAL DISTRIBUTOR INFORMED THE INTERNATIONAL REPRESENTATIVE OF THE FOLLOWING; PT WAS ON HEMOFILTRATION MACHINE. THEIR VASCATH HAD BEEN IN FOR 2 DAYS. THE MACHINE BEGAN TO ALARM HIGH ACCESS PRESSURE WHEN FACILITY TRIED TO REPOSITION THE AS BATH, FACILITY NOTICED THAT THE BLUE LUMEN WAS LEAKING BLOOD FROM PLASTIC STRETCHY TUBE. FILTRATION HAD TO BE D/C AND VASCATH REMOVED. PHYSICIAN INFORMED AND VASCATH CHECKED BY INJECTING NORMAL SALINE VIA LUMEN. WHEN LUMEN WAS PULLED THERE WAS A DEFINITE JET OF WATER FROM A PIN PRICK SIZED HOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIRCLE "C" DUAL LUMEN CATHETER KIT | ACUTE CATHETERS | KOC | HORIZON MEDICAL PRODUCTS, INC. | DLC-600KC | SE00466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |