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