FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH 200, LLC
MDR report key: 19826413
·
Received July 25, 2024
Report
- Report Number
- 19826413
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Date of Event
- June 11, 2024
- Report Date
- June 25, 2024
- Manufacturer
- CARDINAL HEALTH 200, LLC
- Product Code
- OHM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
WHEN OPENING C-SECTION PACK FOR A STAT CASE, 60CC BULB SYRINGE WAS MISSING WITHOUT NOTICE ON PACKAGING. STAFF WAS ABLE TO GET ANOTHER STERILE 60CC SYRINGE FROM SUPPLY CLOSET TO ADD TO PACK. NO PATIENT HARM RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2408063 | CARDINAL HEALTH 200, LLC | CESAREAN SECTION KIT | OHM | CARDINAL HEALTH 200, LLC | 258166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 DA | Female |