FDA Adverse Event
Malfunction
Summary report: N
HYDROPICC
MDR report key: 12433180
·
Received September 7, 2021
Report
- Report Number
- 3015060232-2021-00004
- Event Type
- Malfunction
- Date Received
- September 7, 2021
- Report Date
- September 7, 2021
- Manufacturer
- ACCESS VASCULAR, INC.
- Product Code
- LJS
- UDI-DI
- 00862559000449
- PMA / PMN Number
- K193015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE LHR FOR FG-PICC-142 LOT #09032001 WAS PERFORMED AND DID NOT REVEAL ANY ANOMALIES OR DEVIATIONS OR NONCONFORMANCES.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED THAT WHEN THE HYDROPICC WAS REMOVED, A "HUGE CLOT WAS IN/ON THE CATHETER" AND WAS COMPLETELY OCCLUDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1334064 | HYDROPICC | CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS | LJS | ACCESS VASCULAR, INC. | PICC-142 | 09032001 | 00862559000449 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |