FDA Adverse Event
Malfunction
Summary report: N
CENTURION
MDR report key: 23413051
·
Received October 29, 2025
Report
- Report Number
- 23413051
- Event Type
- Malfunction
- Date Received
- October 29, 2025
- Date of Event
- September 29, 2025
- Report Date
- September 29, 2025
- Manufacturer
- CENTURION MEDICAL PRODUCTS CORPORATION
- Product Code
- JZF
- 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
A HAIR WAS SEEN INSIDE THE PACKAGING OF STERILE EAR TUBING. A NEW TUBING WAS OBTAINED AND OPENED. THE PACKAGING WITH THE HAIR REMAINED CLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2741567 | CENTURION | TUBE, EAR SUCTION | JZF | CENTURION MEDICAL PRODUCTS CORPORATION | EART24ST | 2025031390 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |