FDA Adverse Event
Malfunction
Summary report: N
HYDROMID
MDR report key: 25260363
·
Received May 22, 2026
Report
- Report Number
- 3021570645-2026-00004
- Event Type
- Malfunction
- Date Received
- May 22, 2026
- Date of Event
- April 22, 2026
- Report Date
- May 22, 2026
- Manufacturer
- ACCESS VASCULAR, INC.
- Product Code
- FOZ
- PMA / PMN Number
- K220772
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- 117
Narratives
Additional Manufacturer Narrative · 0
DEVICE RETURNED FOR EVALUATION. PROXIMAL LUER HUB FITTING WAS DETACHED FROM EXTENSION TUBE. EXTENSION TUBE ENTIRELY INTACT, SUGGESTING BOND FAILURE BETWEEN THE LUER HUB AND EXTENSION TUBE. NO CLEAR ROOT CAUSE ON WHAT CAUSED THE SEPERATION.
Description of Event or Problem · 0
COMPANY CONTACTED BY NURSE REPORTER REGARDING A HYDROMID CATHETER THAT LEAKED FROM THE PROXIMAL HUB. THE CATHETER WAS REMOVED AND REPLACED WITH NO CLINICAL IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13979 | HYDROMID | INTRAVASCULAR CATHETER | FOZ | ACCESS VASCULAR, INC. | MID-141 | 05052504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |