BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 21946499 · Received May 1, 2025

    Report

    Report Number
    1423537-2025-00188
    Event Type
    Injury
    Date Received
    May 1, 2025
    Report Date
    May 13, 2025
    Manufacturer
    FIRSTAR HEALTHCARE COMPANY LIMITED
    Product Code
    GCY
    UDI-DI
    10192253016444
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. PRIOR TO A LOT'S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. INSTRUCTIONS FOR USE STATE THAT THE DRAIN MUST NOT BE ALLOWED TO BECOME OCCLUDED NOR THE RESERVOIR TO COMPLETELY FILL, AS ALL WOUND DRAINAGE CEASES. IF OCCLUSION DOES OCCUR, THE DRAIN CAN BE ASPIRATED BY CONNECTING SUCTION TO PORT B OR BY APPLYING SUCTION DIRECTLY TO THE DRAIN. IF THE RESERVOIR IS NOT EMPTIED WHEN IT IS FULL, THE LIKELIHOOD OF BACK-CONTAMINATION INCREASES. NO SIMILAR COMPLAINT HAS BEEN RECEIVED REGARDING THIS REPORTED INCIDENT. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEIR UNIT HAS BEEN HAVING ISSUES WITH THE CARDINAL HEALTH¿ JACKSON-PRATT® PVC ROUND DRAIN 3-SPRING RESERVOIR KIT WITH TROCAR, 400ML, 19FR FOR OVER A YEAR. THEY ARE JUST NOW REPORTING IT BECAUSE THEY DIDN'T KNOW WHO TO REPORT TO. THE DRAIN IS CLOGGING IN THE TUBING EVERY 12 HOURS POST-OPERATIVELY. THEY ARE HAVING TO MANUALLY UNCLOG THEM. THEY HAVE HAD PATIENTS START BLEEDING BUT NO FURTHER INFORMATION WAS PROVIDED TO CARDINAL, AND ONE PATIENT HAD A DROP FOOT DUE TO THE DRAIN AND HAD TO GO BACK INTO SURGERY. THE ISSUE WAS REPORTED TO THE OR MANAGER AT THE TIME. THEY DID NOT KEEP THE DRAIN(S) THAT WERE CAUSING THE ISSUE AND DO NOT HAVE SAMPLES OR LOT NUMBERS. THEY CHANGED TO A NEW TYPE OF DRAIN - THE BULB JP DRAIN FROM CARDINAL. EXACT EVENT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935081 CARDINAL HEALTH APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY FIRSTAR HEALTHCARE COMPANY LIMITED SU130-404D 10192253016444

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H