FDA Adverse Event
Malfunction
Summary report: N
PICC LINE
MDR report key: 3840174
·
Received May 22, 2014
Report
- Report Number
- MW5036330
- Event Type
- Malfunction
- Date Received
- May 22, 2014
- Date of Event
- May 13, 2014
- Report Date
- May 21, 2014
- Manufacturer
- BARD
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
INFANT FOUND WITH PCVC DRESSING INTACT, AND PCVC CATHETER BROKEN OFF FROM ANCHOR DEVICE. LINE WAS DISCONTINUED, PARENTS WERE NOTIFIED. DOCTOR AWARE. INFANT SHOWED NO SIGNS OF HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304386 | PICC LINE | PICC LINE | LJS | BARD | PER-Q-CATH PICC | REXL0169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |