FDA Adverse Event
Other
Summary report: N
POWER PICC SOLO 2
MDR report key: 4044426
·
Received August 22, 2014
Report
- Report Number
- 4044426
- Event Type
- Other
- Date Received
- August 22, 2014
- Date of Event
- July 22, 2014
- Report Date
- August 21, 2014
- Manufacturer
- BARD ACCESS SYSTEMS, INC.
- Product Code
- LJS
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT TO INTERVENTIONAL RADIOLOGY FOR PLACEMENT OF A PICC LINE. AT THE END OF THE PROCEDURE WHILE REMOVING THE WIRE, A SMALL THREAD OF WIRE WAS DISCONNECTED AND REMAINS IN THE SOFT TISSUE IN THE MID RIGHT ARM REGION. PT HAS A HAS A RETAINED 4.6 MILLIMETER PIECE OF GUIDEWIRE THAT IS COMPLETELY ENCASED IN HER SOFT TISSUE AND NOT INVOLVING THE RIGHT BASILIC VEIN. AFTER THE PIECE BROKE OFF, THE WIRE WAS NOT USED AND THROWN AWAY.NO LOT NUMBER IS ABLE TO BE OBTAINED BECAUSE THE PICC WAS NOT PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508752 | POWER PICC SOLO 2 | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 | LJS | BARD ACCESS SYSTEMS, INC. | 3295335 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other | NO OTHER THERAPIES |