FDA Adverse Event
Malfunction
Summary report: N
PERIPHERALLY INSERTED CENTRAL CATHETER
MDR report key: 36457
·
Received September 4, 1996
Report
- Report Number
- MW1009855
- Event Type
- Malfunction
- Date Received
- September 4, 1996
- Date of Event
- July 25, 1996
- Report Date
- July 29, 1996
- Manufacturer
- LUTHER MEDICAL PRODUCTS, INC.
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT'S PICC LINE WAS PLACED 7/22/96 AT THE HOSP. WAS FLUSHING VERY SLUGGISHLY AND WITH SOME PRESSURE NEEDED TO FLUSH. ATTEMPTED TO FLUSH WITH UROKINASE TWICE BUT WAS UNSUCCESSFUL. LINE WAS PULLED ON 7/25/96 BECAUSE IT WOULD NO LONGER FLUSH AND WAS NON-FUNCTIONAL. CXR INDICATED CATHETER WAS INTACT AND IN CORRECT PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERIPHERALLY INSERTED CENTRAL CATHETER Implant | PERIPHERALLY INSERTED CENTRAL CATHETER | DQO | LUTHER MEDICAL PRODUCTS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Other |