BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19055688 · Received April 5, 2024

    Report

    Report Number
    1423537-2024-00014
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 29, 2024
    Manufacturer
    DEGANIA SILICONE, INC.
    Product Code
    KGZ
    UDI-DI
    10885380182570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACTUAL SAMPLE WAS NOT AVAILABLE FOR EVALUATION, THEREFORE THE ROOT CAUSE FOR THE DRAIN BREAKAGE COULD NOT BE CONFIRMED. THE BATCH P22114004 (4000 PCS., PROD. DATE 15/05/23, EXP. DATE 15/05/28), SUCCESSFULLY PASSED SAMPLING SIZE SUFFICIENCY TEST TO ENSURE THAT THE DRAINS ARE FUNCTIONING PROPERLY . SUPPLIER¿S IN-PROCESS CONTROL INCLUDES TENSILE STRENGTH TEST OF EVERY BATCH OF THE DRAINS. THE BATCH PASSED THE TENSILE STRENGTH TEST (TEAR TEST) IN THE CONNECTION AREA. ALL THE RESULTS WERE HIGHER THAN MINIMUM REQUIREMENT ACCORDING TO THE TEST SPECIFICATION. THE DRAIN MAY HAVE BEEN PUNCTURED BY A SHARP OBJECT DURING USE, RESULTING IN A SMALL CUT THAT LED TO LEAKAGE. SUBSEQUENTLY, WHEN THE DOCTOR MANIPULATED THE DRAIN, THE CUT MAY HAVE SPREAD ALONG ITS LENGTH, MOST LIKELY THE DRAIN FAILED DUE TO SOME DAMAGE IN USE. ONE OF THE PROPERTIES OF SILICONE DRAINS IS TO SNAP EASILY IN PLACE OF EVEN SLIGHT CUT OR NICK.

    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.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE PRODUCT WAS PLACED EARLY LAST WEEK. PATIENT WENT TO ANOTHER UNIT AND THE DRAIN WASN¿T PRODUCING ANYTHING. THE DOCTOR ASSUMED IT WAS JUST THE BULB THAT WAS THE ISSUE, SO SHE REPLACED THE BULB. NOTHING RESULTED FROM THIS. IT TURNED OUT THERE WAS AN AIR LEAK WHICH CAUSED THE DRAIN TO HAVE NO SUCTION. WHEN THE DOCTOR WENT TO MANIPULATE THE ACTUAL DRAIN LINE IT FELL APART AND COMPLETELY PULLED OUT WITH THE SUTURE ATTACHED TO THE END. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729957 JP CHAN DRN SIL RND 19FR 3/4 W/TRO ACCESSORIES, CATHETER KGZ DEGANIA SILICONE, INC. JP-2225 P22114004 10885380182570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other