BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JACKSON-PRATT CHANNEL DRAIN

    MDR report key: 8746787 · Received June 30, 2019

    Report

    Report Number
    8030107-2019-00007
    Event Type
    Malfunction
    Date Received
    June 30, 2019
    Date of Event
    May 9, 2019
    Report Date
    May 20, 2019
    Manufacturer
    DEGANIA SILICONE LTD
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    8030107-06/28/2019-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAS 2 JP DRAINS POST SURGERY. BOTH DRAINS WERE REMOVED WITHOUT INCIDENT WHILE PT WAS INPATIENT. PATENT RETURNED TO THE ED A FEW DAY POST D/C WITH ABDOMINAL PAIN AND VOMITING. IT WAS FOUND THAT THERE WAS A DRAIN IN THE ABDOMEN THAT WAS NOT EXPECTED TO BE THERE AS THEY WERE REMOVED BEFORE SHE WAS DISCHARGED. SURGICAL REMOVAL OF THE REMAINING DRAIN WAS NEEDED. FDA SAFETY REPORT ID# (B)(4). WE CHECKED THE RETAIN SAMPLES OF THE THREE RECENTLY PRODUCED LOTS OF THE SAME CODE, WITHOUT FINDINGS. THE PRODUCTION CONTROLS OF THIS CODE INCLUDES 100% VISUAL INSPECTION FOR ANY DAMAGE WHICH COULD LEAD TO TEAR. WE CHECKED THE TENSILE TEST RESULTS OF THE RECENT PRODUCTION LOT P1868563 OF JP-2188 (11003801580CR). FOR THIS LOT, THE MIN. RESULT IS 77.24N AND THE AVERAGE RESULT IS 94,77N. THIS RESULT IS MUCH HIGHER THAN THE 15N MIN. REQUIRED BY THE ISO STANDARD EN1617, SECTION 4.3.1. "FORCE AT BREAK - CONNECTIONS". UPDATE OF 06/30/2019: THE BREAKAGE WAS ASSOCIATED WITH THE NEW TOOL USED FOR THE PRODUCTION OF CONNECTOR WHICH CONNECTS CLEAR TUBE AND WHITE DRAINING PORTION IN THESE DRAINS. ON 06/28/2019 WE INITIATED RECALL #8030107-06/28/2019-001-R TO REMOVE ALL DRAINS IN WHICH NEW DESIGN OF CONNECTORS WAS USED.

    Description of Event or Problem · 1

    PATIENT HAS 2 JP DRAINS POST SURGERY. BOTH DRAINS WERE REMOVED WITHOUT INCIDENT WHILE PT WAS INPATIENT. PATENT RETURNED TO THE ED A FEW DAY POST D/C WITH ABDOMINAL PAIN AND VOMITING. IT WAS FOUND THAT THERE WAS A DRAIN IN THE ABDOMEN THAT WAS NOT EXPECTED TO BE THERE AS THEY WERE REMOVED BEFORE SHE WAS DISCHARGED. SURGICAL REMOVAL OF THE REMAINING DRAIN WAS NEEDED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540408 JACKSON-PRATT CHANNEL DRAIN SILICONE FLUTED 15FR DRAIN GCB DEGANIA SILICONE LTD JP-2188 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention