FDA Adverse Event
Other
Summary report: N
CIRCLE C SILICONE CATHETER KIT
MDR report key: 246155
·
Received October 26, 1999
Report
- Report Number
- 1056436-1999-00184
- Event Type
- Other
- Date Received
- October 26, 1999
- Date of Event
- October 5, 1999
- Report Date
- October 7, 1999
- Manufacturer
- NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC
- Product Code
- FJS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ON 10/07/1999, THE DISTRIBUTOR'S SALES REP INFORMED THE MFR THAT A CUSTOMER IN HIS TERRITORY EXPERIENCED TWO (2) PROBLEMS (REF MDR# 1056436-1999-183 FOR FIRST PROBLEM) WITH THIS PRODUCT; HOWEVER, HE DID NOT HAVE ALL THE INFO AVAILABLE. ON 10/11/1999, THE MFR RECEIVED A FAXED REPORT FROM THE DISTRIBUTOR'S SALES REP THAT STATES THE FOLLOWING: PER THE FACILITY'S CLINICAL NURSE SPECIALIST, HOLES IN CATHETER EXTENSIONS. PT'S WHO ARE RECEIVING REPLACEMENT CATHETERS. SOME ARE SHOWING UP WITH PINHOLES IN EXTENSIONS. ADD'L INFO STATES THAT THE CATHETER WAS PLACED OVER GUIDEWIRE 10/01/1999. HOLES NOTED 10/05/1999 AT DIALYSIS. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIRCLE C SILICONE CATHETER KIT Implant | CHRONIC SILICONE CATHETER | FJS | NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |