FDA Adverse Event
Malfunction
Summary report: N
2 FR PER-Q-CATH PLUS PICC WITH STYLET, BASIC
MDR report key: 2980672
·
Received February 22, 2013
Report
- Report Number
- 3006260740-2013-00080
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- August 9, 2012
- Report Date
- February 6, 2013
- Manufacturer
- C. R. BARD INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K954104
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
IT IS REPORTED THAT DURING THE PASSAGE OF THE PICC, IT WAS OBSERVED THAT IT HAD MICROHOLES IN THE FIRST THIRD PART OF THE CATHETER. THROUGH THE MICROHOLES WAS LEAKAGE OF SALINE WHICH WAS BEING USED FOR TESTING. THE CATHETER WAS NEVER IMPLANTED IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77635 | 2 FR PER-Q-CATH PLUS PICC WITH STYLET, BASIC | LJS | C. R. BARD INC. (BASD) | REVF0370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |