BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JP CHAN DRN SIL RND 19FR 3/4 W/TRO

    MDR report key: 19399229 · Received May 26, 2024

    Report

    Report Number
    1423537-2024-00019
    Event Type
    Injury
    Date Received
    May 26, 2024
    Date of Event
    March 6, 2024
    Report Date
    August 6, 2024
    Manufacturer
    DEGANIA SILICONE, INC.
    Product Code
    KGZ
    UDI-DI
    10885380182570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD REVIEW FOR BATCH NUMBER P22114003 SHOWED (B)(4) PIECES PRODUCED 08/22/23, WITH EXPIRATION DATE OF 01/24/2028. A SAMPLE WAS RETURNED FOR EVALUATION WITH A WIRE TIED AROUND THE CONNECTION POINT. THE SUPPLIER¿S IN-PROCESS CONTROL CONTAINS TENSILE STRENGTH TEST OF EVERY BATCH OF DRAINS. TESTING FROM RETAINED SAMPLE FROM THE SAME BATCH PASSED TENSILE STRENGTH TEST AND THE RESULT WAS COMPLIANT WITHIN TEST SPECIFICATION. BASED ON TESTING AND THE INFORMATION PROVIDED, THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    MW5153800: CUSTOMER REPORTED THAT JACKSON-PRATT DRAIN WAS PLACED IN PATIENT MONDAY, FOLLOWING PANNICULECTOMY. PATIENT EVALUATED WITH JP TUBING AMPUTATED AT GLUED PORTION OF TUBING AND TUNNELING DEVICE CONSISTENT WITH FAILED/FAULTY JP DRAIN. TUNNELED TUBING WAS EMBEDDED INTO THE ABDOMINAL WALL REQUIRING REPEAT SURGERY AND REMOVAL OF FOREIGN BODY. NO OTHER MANUFACTURER JP DRAIN AVAILABLE. PATIENT WAS DISCHARGED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329595 JP CHAN DRN SIL RND 19FR 3/4 W/TRO ACCESSORIES, CATHETER KGZ DEGANIA SILICONE, INC. JP-2225 P22114003 10885380182570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization