FDA Adverse Event
Malfunction
Summary report: N
DRAINAGE BAG
MDR report key: 23887814
·
Received December 24, 2025
Report
- Report Number
- 23887814
- Event Type
- Malfunction
- Date Received
- December 24, 2025
- Date of Event
- November 13, 2025
- Report Date
- December 8, 2025
- Manufacturer
- REMINGTON MEDICAL, INC.
- Product Code
- EXF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT CAME BACK FROM IR [INTERVENTIONAL RADIOLOGY] AND WAS FOUND TO HAVE NEPHROSTOMY TUBE DISCONNECTED. LOOKS LIKE IT BECAME DETACHED AT THE Y JUNCTION. PHYSICIAN NOTIFIED AND TUBE CLAMPED AND STERILE GAUZE PLACED ON END.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2507172 | DRAINAGE BAG | BAG, BILE COLLECTING | EXF | REMINGTON MEDICAL, INC. | 600-D | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |