FDA Adverse Event
Malfunction
Summary report: N
12.5FX28CM PC HEMO-CATH
MDR report key: 3442401
·
Received September 20, 2013
Report
- Report Number
- 2518902-2013-00052
- Event Type
- Malfunction
- Date Received
- September 20, 2013
- Date of Event
- April 22, 2013
- Report Date
- September 18, 2013
- Manufacturer
- MEDCOMP
- Product Code
- MSD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EC
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED FOR EVAL. A REVIEW OF THE MFG RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. THIS PRODUCT LINE IS 100% LEAK TESTED DURING THE MFG PROCESS. W/O AN EVAL OF THE DEVICE INVOLVED WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.
Description of Event or Problem · 1
PIN HOLES ON THE EXTENSION, BLOOD LEAKS NEAR THE CLAMP. CATHETER WAS REMOVED. BLOOD LOSS WAS <20CC AND NO ILL EFFECTS TO THE PT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475879 | 12.5FX28CM PC HEMO-CATH | HEMODIALYSIS CATHETER | MSD | MEDCOMP | SL28PCE | MBCF790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |