FDA Adverse Event
Malfunction
Summary report: N
12.5FX28CM HEMO-CATH
MDR report key: 3442380
·
Received September 20, 2013
Report
- Report Number
- 2518902-2013-00054
- Event Type
- Malfunction
- Date Received
- September 20, 2013
- Date of Event
- July 29, 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 DEVICE FAMILY IS 100% LEAK TESTED DURING MFG. 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
AFTER THE INSERTION PROCESS OF THE CATHETER, WE HAVE NOTICED THAT AT THE EXTENSIONS THERE ARE TINY PIN HOLES THAT LEAKS BLOOD AND LIQUID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 476126 | 12.5FX28CM HEMO-CATH | HEMODIALYSIS CATHETER | MSD | MEDCOMP | SL28PCE | MBCF790 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |