FDA Adverse Event
Malfunction
Summary report: N
MEDCOMP DUAL LUMEN VASCU PICC
MDR report key: 8189862
·
Received December 20, 2018
Report
- Report Number
- MW5082411
- Event Type
- Malfunction
- Date Received
- December 20, 2018
- Date of Event
- December 12, 2018
- Report Date
- December 19, 2018
- Manufacturer
- MEDICAL COMPONENTS INC. (DBA MEDCOMP)
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PATIENT HAD PICC LINE PLACED IN RIGHT ARM, AND PICC CATHETER FRACTURED WHILE INSIDE PATIENT'S ARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1027453 | MEDCOMP DUAL LUMEN VASCU PICC | CATHETER, INTRAVASCULAR, THERAPEUTIC LONG-TERM GREATER THAN 30 DAYS | LJS | MEDICAL COMPONENTS INC. (DBA MEDCOMP) | MLNH110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 MO | Other |