BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON-PRATT SILICONE FLAT DRAIN 10MMX20CM

    MDR report key: 5909841 · Received August 29, 2016

    Report

    Report Number
    5909841
    Event Type
    Malfunction
    Date Received
    August 29, 2016
    Date of Event
    August 18, 2016
    Report Date
    August 25, 2016
    Manufacturer
    CARDINAL HEALTH 200 LLC
    Product Code
    OTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD FIRST POST-OP CLINIC VISIT. DURING ATTEMPT TO REMOVE 2 JP DRAINS, THEY SNAPPED OFF AND PORTION REMAINED IN PT. PT SCHEDULED TO UNDERGO SURGERY THE NEXT DAY FOR REMOVAL. PT UNDERWENT EXPLORATORY LAPAROTOMY AND REMOVAL OF RETAINED DRAINS UNDER GENERAL ANESTHESIA. NO COMPLICATIONS AND PT DISCHARGED HOME. PER SURGEON, DRAIN WAS NOT CAUGHT IN SUTURE LINE AND HAD NOT BEEN DAMAGED/MELTED BY CAUTERY. STATED SAW NO MARKS OR ISSUES WITH DRAIN WHEN SURGICALLY REMOVED THEM. STATED NO KNOWN REASON FOR THE DRAINS TO SNAP. THE PORTION THAT BROKE OFF IN CLINIC WERE NOT SAVED SO ONLY THE PORTION IN PT THAT WERE SURGICALLY REMOVED AVAILABLE TO SEND TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562627 JACKSON-PRATT SILICONE FLAT DRAIN 10MMX20CM DRAIN, WOUND, CATHETER OTK CARDINAL HEALTH 200 LLC P1504640

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR