FDA Adverse Event
Malfunction
Summary report: N
14F X 24CM SPLIT STREAM
MDR report key: 2961131
·
Received February 8, 2013
Report
- Report Number
- 2518902-2013-00002
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- December 15, 2012
- Report Date
- February 5, 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
"JUST AFTER CONNECTION TO EXTRA-CORPORAL CIRCUIT THE NURSE REALIZED THAT THERE WAS AIR IN THE ARTERIAL LINE. THE TREATMENT WAS IMMEDIATELY STOPPED AND A RUPTURE WAS DETECTED IN THE JUNCTION BETWEEN BOTH CATHETER BRANCHES. THE PT WAS SENT TO HOSPITAL TO REMOVE CATHETER."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 54697 | 14F X 24CM SPLIT STREAM | HEMODIALYSIS CATHETER | MSD | MEDCOMP | SST24E | MBHA890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |