FDA Adverse Event
Malfunction
Summary report: N
14F 28CM SPLIT STREAM
MDR report key: 3102141
·
Received May 3, 2013
Report
- Report Number
- 2518902-2013-00021
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- January 18, 2013
- Report Date
- May 2, 2013
- Manufacturer
- MEDCOMP
- Product Code
- MSD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION HAS BEEN INITIATED. WHEN THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
TWO HOURS FROM THE BEGINNING OF THE DIALYSIS TREATMENT THE NURSE REALIZED THAT THERE WAS SOME BLOOD LEAKING FROM THE CATHETER. A RUPTURE WAS DETECTED IN THE JUNCTION BETWEEN BOTH CATHETER BRANCHES. TREATMENT WAS IMMEDIATELY STOPPED AND PATIENT WAS SENT TO HOSPITAL TO REMOVE THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195301 | 14F 28CM SPLIT STREAM | HEMODIALYSIS CATHETER | MSD | MEDCOMP | SST28E | MATG840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |