FDA Adverse Event
Malfunction
Summary report: N
MEDLINE 100% SILICONE 1-LAYER FOLEY CATHETER TRAY WITH DRAIN BAG
MDR report key: 20224292
·
Received September 16, 2024
Report
- Report Number
- 20224292
- Event Type
- Malfunction
- Date Received
- September 16, 2024
- Date of Event
- July 17, 2024
- Report Date
- July 8, 2024
- Manufacturer
- MEDLINE INDUSTRIES, LP - NORTHFIELD
- Product Code
- OHR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MEDLINE FOLEY CATHETER KIT (REF DYND160716). CATHETER INSERTED WITHOUT ISSUE. UNABLE TO INFLATE BALLOON (COULD NOT PRESS SYRINGE). A SECOND KIT WAS OPENED. FOLEY AGAIN INSERTED, AND AGAIN COULD NOT INFLATE BALLOON. (BOTH LOT# (10)24DBI601). INCREASED RISK OF HAI WITH MULTIPLE FOLEY ATTEMPT. NO HARM AND NO INJURY NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1495550 | MEDLINE 100% SILICONE 1-LAYER FOLEY CATHETER TRAY WITH DRAIN BAG | CATHETER CARE TRAY | OHR | MEDLINE INDUSTRIES, LP - NORTHFIELD | DYND160716 | BOTH LOT# (10)24DBI601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female |