FDA Adverse Event
Injury
Summary report: N
PER-Q-CATH PLUS 3 FR. S/L PICC
MDR report key: 1022013
·
Received March 31, 2008
Report
- Report Number
- 2523003-2008-00020
- Event Type
- Injury
- Date Received
- March 31, 2008
- Date of Event
- February 28, 2008
- Report Date
- March 7, 2008
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K954104
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A CHR REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LINE WAS REMOVED, THE PT WAS FEELING CHEST PAIN, WHEN AN X-RAY WAS DONE, THEY FOUND THAT THE MESH THAT INVOLVES THE GUIDEWIRE WAS NEAR HIS HEART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PER-Q-CATH PLUS 3 FR. S/L PICC | LJS | C.R. BARD, INC. (BASD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |