FDA Adverse Event
Malfunction
Summary report: N
SET,IRRIGATION,4-LEAD,90"
MDR report key: 16283405
·
Received February 2, 2023
Report
- Report Number
- 16283405
- Event Type
- Malfunction
- Date Received
- February 2, 2023
- Date of Event
- January 16, 2023
- Report Date
- January 25, 2023
- Manufacturer
- MEDLINE INDUSTRIES, LP - NORTHFIELD
- Product Code
- LJH
- UDI-DI
- 10080196993833
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
MEDLINE TUBING KEPT KINKING AND INTERRUPTED FLOW OF FLUIDS NEEDED FOR THE SURGERY, EXTENDING DURATION OF SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387726 | SET,IRRIGATION,4-LEAD,90" | SYSTEM, IRRIGATION, UROLOGICAL | LJH | MEDLINE INDUSTRIES, LP - NORTHFIELD | DYND19124 | (10)18322060001 | 10080196993833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24455 DA | Unknown |