FDA Adverse Event
Malfunction
Summary report: N
45 CM, 5 FR. S/L POWER GROSHONG, BASIC KIT
MDR report key: 1930275
·
Received November 18, 2010
Report
- Report Number
- 3006260740-2010-00341
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- October 12, 2010
- Report Date
- October 27, 2010
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K063848
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER WOULD NOT ASPIRATE. PT WENT TO RADIOLOGY AND A HOLE WAS DISCOVERED IN THE LINE. THE PICC WAS REMOVED AND THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 45 CM, 5 FR. S/L POWER GROSHONG, BASIC KIT | LJS | C. R. BARD INC. (BASD) | REUE0585 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |