FDA Adverse Event
Malfunction
Summary report: N
POWERGLIDE MIDLINE CATHETER
MDR report key: 4080815
·
Received September 5, 2014
Report
- Report Number
- MW5038119
- Event Type
- Malfunction
- Date Received
- September 5, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 5, 2014
- Manufacturer
- BARD ACCESS SYSTEMS, INC.
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OK, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A POWERGLIDE MIDLINE CATHETER WAS INSERTED INTO THE PT'S LEFT CEPHALIC VEIN. NO PROBLEMS WITH INSERTION, BUT WHEN THE MIDLINE DEVICE WAS DETACHED FROM THE CATHETER, THERE WAS NO GUIDEWIRE IN PLACE. AT THAT POINT, THE CATHETER WAS DISCONTINUED. X-RAYS AND SCANS WERE COMPLETED ON THE ARM AND ON THE CHEST. NO GUIDEWIRE WAS EVER FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543277 | POWERGLIDE MIDLINE CATHETER | MIDLINE CATHETER | FOZ | BARD ACCESS SYSTEMS, INC. | REYG0297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |