BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOSEAL

    MDR report key: 7810099 · Received August 23, 2018

    Report

    Report Number
    1416980-2018-05349
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    July 30, 2018
    Report Date
    September 26, 2018
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED VIA THE NAKED EYE WITH ISSUES NOTED. THE ACTUAL SAMPLE WAS SENT BACK IN THE KIT BOX WITH UNOPENED ITEMS AND LOOSE GELATIN GRANULES WERE SCATTERED ALL OVER THE FLOSEAL GELATIN POUCH. THE FLOSEAL POUCH WAS OPENED FOR FURTHER INSPECTION. THE GELATIN GRANULES SPILLED OUT OF THE FLOSEAL GELATIN SYRINGE BECAUSE THE LUER PLUG WAS MISSING. THE REPORTED ISSUE WAS VERIFIED. THE CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: THE CUSTOMER REPORTED THAT THIS PRODUCT HAD A LOT NUMBER OF 180263; HOWEVER, THIS LOT NUMBER IS NOT RECOGNIZED BY BAXTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE APPEARED TO BE LOOSE GELATIN GRANULES IN THE STERILE PACKAGING OF A FLOSEAL HEMOSTATIC MATRIX KIT. THIS WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651107 FLOSEAL AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD NA HA180263

    Patients

    Seq Age Sex Outcome Treatment
    1