BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGEL PLEURAL AIR LEAK SEALANT SYRINGE 4 ML PROGEL

    MDR report key: 12786815 · Received November 9, 2021

    Report

    Report Number
    MW5105219
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 5, 2021
    Manufacturer
    NEOMEND INC.
    Product Code
    NBE
    UDI-DI
    00801741010026
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD A RIGHT THORACOTOMY/DECORTICATION SURGERY. THE SURGEON WAS USING SEVERAL OF THE PROGEL SYRINGES DURING THE CASE (PLEURAL AIR LEAK SEALANT). AS HE BEGAN TO INJECT THE PROGEL INTO THE CHEST CAVITY, ONE OF THE SYRINGES BROKE INSIDE THE SYRINGE CHAMBER. HE WAS UNABLE TO GET ANY PROGEL OUT OF THE TIP OF THE SYRINGE AT THIS POINT. A FEW SHARDS FROM THE SYRINGE LANDED ON THE STERILE DRAPE. THE CHEST CAVITY WAS INSPECTED AND NO SYRINGE SHARDS WERE FOUND. THE SYRINGE WAS IMMEDIATELY REMOVED FROM THE FIELD AND STERILITY MAINTAINED. NO HARM CAME TO THE PATIENT, POST-OPERATIVE CHEST X-RAY DOES NOT SHOW FOREIGN BODY IN PATIENT'S CHEST. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679923 PROGEL PLEURAL AIR LEAK SEALANT SYRINGE 4 ML PROGEL SEALANT, POLYMERIZING NBE NEOMEND INC. M-00331 IRFV0030 00801741010026

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male