FDA Adverse Event
Malfunction
Summary report: N
EZL
MDR report key: 22915822
·
Received August 28, 2025
Report
- Report Number
- 1417592-2025-00427
- Event Type
- Malfunction
- Date Received
- August 28, 2025
- Date of Event
- June 1, 2025
- Report Date
- March 13, 2026
- Manufacturer
- MEDLINE INDUSTRIES LP
- Product Code
- EZL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPDATED D2B, G6, H2.
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE CATHETER BECAME "DISLODGED" AND THERE WERE HOLES NOTED IN THE CATHETER. DUE TO THIS, THE DEVICE WAS REPLACED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem · 0
URINARY CATHETER BECAME DISLODGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392346 | EZL | DIV18 CRITICAL CARE - MISCELLANEOUS | EZL | MEDLINE INDUSTRIES LP | 592211016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |