REGARD
Report
- Report Number
- 3004513970-2024-00002
- Event Type
- Malfunction
- Date Received
- September 25, 2024
- Date of Event
- September 6, 2024
- Report Date
- September 25, 2024
- Manufacturer
- RESOURCE OPTIMIZATION & INNOVATION, LLC
- Product Code
- FYC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
RESOURCE OPTIMIZATION & INNOVATION, LLC PERSONNEL CONDUCTED A SITE VISIT AT THE USER FACILITY AS PART OF THE INVESTIGATION INTO THE REPORTED EVENT. THE USER OF THE GOWN CONFIRMED THAT THEY USED A GOWN THAT WAS TOO SMALL AND THAT THEY DID NOT COVER THE WRIST CUFF WITH GLOVES AS REQUIRED. THE FLUID STRIKE THROUGH WAS PRESENT ONLY ON THE CUFF OF THE GOWN AND NOT ON THE AREAS OF THE GOWN WHERE FLUID PROTECTION IS PROVIDED.
RESOURCE OPTIMIZATION & INNOVATION, LLC PERSONNEL CONDUCTED A SITE VISIT AT THE USER FACILITY AS PART OF THE INVESTIGATION INTO THE REPORTED EVENT. THE USER OF THE GOWN CONFIRMED THAT THEY USED A GOWN THAT WAS TOO SMALL AND THAT THEY DID NOT COVER THE WRIST CUFF WITH GLOVES AS REQUIRED. THE FLUID STRIKE THROUGH WAS PRESENT ONLY ON THE CUFF OF THE GOWN AND NOT ON THE AREAS OF THE GOWN WHERE FLUID PROTECTION IS PROVIDED. FOLLOW UP 1-INVESTIGATION RESULTS: SEE ATTACHED "INCI115625-CLOSURE LETTER-INVESTIGATION RESULTS".
THE BILE FROM A CASE TODAY LEAKED THROUGH THE CUFF OF THE GOWN.
THE BILE FROM A CASE TODAY LEAKED THROUGH THE CUFF OF THE GOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1243188 | REGARD | GOWN ISOLATION AAMI 3 BLUE CUFF, UL | FYC | RESOURCE OPTIMIZATION & INNOVATION, LLC | A3ISOGULNS-REG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |