FDA Adverse Event
Malfunction
Summary report: N
NUTRILINE TWINFLO
MDR report key: 7845751
·
Received September 5, 2018
Report
- Report Number
- 2245270-2018-00032
- Event Type
- Malfunction
- Date Received
- September 5, 2018
- Date of Event
- May 7, 2018
- Report Date
- August 30, 2018
- Manufacturer
- VYGON MFG
- Product Code
- LJS
- PMA / PMN Number
- K052475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST.
Description of Event or Problem · 0
PICC DRESSING CHANGE STARTED DUE TO DRIED BLOOD UNDER DRESSING AND DRESSING LIFTING AT INSERTION SITE. OLD DRESSING REMOVED AND DRIED BLOOD REMOVED FROM CATHETER AND INSERTION SITE WITH STERILE ALCOHOL AND CHLORAPREP SWABS. PICC NOTED TO BE LEAKING DISTAL TO INSERTION SITE. MD AND NNP NOTIFIED AND VIEWED. PICC PULLED AND PIV PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690440 | NUTRILINE TWINFLO | LONG-TERM INTRAVASCULAR CATHETER | LJS | VYGON MFG | 1252.232M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 DA | Male |