FDA Adverse Event
Malfunction
Summary report: N
STERILE ULTRASOUND PROBE COVER
MDR report key: 20723105
·
Received November 19, 2024
Report
- Report Number
- 20723105
- Event Type
- Malfunction
- Date Received
- November 19, 2024
- Date of Event
- September 17, 2024
- Report Date
- September 17, 2024
- Manufacturer
- MEDLINE INDUSTRIES, LP
- Product Code
- JOP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
HAIR OR FOREIGN OBJECT DETECTED ON THE INSIDE OF A STERILE ULTRASOUND PROBE COVER DURING PICC LINE SETUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1324996 | STERILE ULTRASOUND PROBE COVER | TRANSDUCER, ULTRASONIC | JOP | MEDLINE INDUSTRIES, LP | 3034MA0100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |