BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET

    MDR report key: 8167898 · Received December 16, 2018

    Report

    Report Number
    1820334-2018-03822
    Event Type
    Malfunction
    Date Received
    December 16, 2018
    Report Date
    December 16, 2018
    Manufacturer
    COOK INC
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS: 5 PACKAGES RETURNED FROM 3 LOTS: 3 X 6156773, 1 X 5800528, 1 X 6063434.THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVER A MONTH'S TIME ((B)(6) TO (B)(6) 2015) DURING TESTING PRIOR TO USE, FIVE CONCORD ENDOSCOPIC CHOLANGIOGRAPHY CATHETERS LEAKED WHERE THE SYRINGE ENTERS AND DOESN'T STAY CONNECTED. IT WAS FURTHER NOTED THAT THE DEVICE WAS LEAKING AT THE HUB. NO ADVERSE EFFECTS TO THE PATIENT(S) WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007220 CONCORD ENDOSCOPIC CHOLANGIOGRAPHY SET GBZ CATHETER, CHOLANGIOGRAPHY GBZ COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1