FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 20332429
·
Received September 30, 2024
Report
- Report Number
- 20332429
- Event Type
- Malfunction
- Date Received
- September 30, 2024
- Date of Event
- June 6, 2024
- Report Date
- June 21, 2024
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- OJG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
WHILE OPENING A NEURO PACK FOR A CASE, THE CAREGIVERS NOTICED THE TABLE COVER HAD A HOLE IN IT. THEY REMOVED AND OBTAINED A NEW STERILE AND INTACT NEURO PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2585117 | CARDINAL HEALTH | NEUROLOGICAL TRAY | OJG | CARDINAL HEALTH 200, LLC | SNE56BS46U | 241520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |