FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH
MDR report key: 17370404
·
Received July 21, 2023
Report
- Report Number
- 17370404
- Event Type
- Malfunction
- Date Received
- July 21, 2023
- Date of Event
- April 26, 2023
- Report Date
- June 29, 2023
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- NWU
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- ME
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
FROM STAFF: DEBRIS/BURN/BUG FOUND IN RAYTEC ENDO PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2194027 | CARDINAL HEALTH | ENDOSCOPE INTRODUCER KIT | NWU | CARDINAL HEALTH 200, LLC | SBA13LCEMD | 987898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 DA | Female |