BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGEL

    MDR report key: 18341624 · Received December 16, 2023

    Report

    Report Number
    3004763499-2023-00002
    Event Type
    Malfunction
    Date Received
    December 16, 2023
    Date of Event
    November 16, 2023
    Report Date
    December 16, 2023
    Manufacturer
    MOLNLYCKE HEALTH CARE
    Product Code
    KGO
    PMA / PMN Number
    K050184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ONGOING TO CONFIRM REPORTED MALFUNCTION. THE REPORTED EVENT HAS NOT LEAD TO AN DEATH OR SERIOUS INJURY; HOWEVER, IF CONFIRMED, THE REPORTED EVENT COULD HAVE LED TO A SERIOUS INJURY. ADDITIONAL REPORT WILL BE FILED AFTER INVESTIGATION IS COMPLETED OR WITHIN THE APPLICABLE TIME FRAME, WHICHEVER COMES FIRST.

    Additional Manufacturer Narrative · 0

    SAMPLE TESTING: THERE WERE 6 PACKS OF RETURNED SAMPLES RECEIVED. ONE OF THE RETURNED PACKS HAS NRL INNER WRAP WITH NRL GLOVES (SIZE 7.5) PACKED IN THE PACKAGE. THE REMAINING PACKS AND RETENTION SAMPLES (2 PACKS) WERE NOT HAVING SIMILAR ABNORMALITIES. INVESTIGATION/ROOT CAUSE ANALYSIS: THE LOT SIZE FOR PACKING LOT NO. 23F6016 BIOGEL SURGEONS 304 - A15 (LATEX) WAS INCREASED FROM 60K PAIRS TO 75K PAIRS DURING THE MIDDLE OF PRODUCTION RUN (SHIFT C), TO MEET THE BUSINESS ORDER. THE STRATIFIED SAMPLES QUANTITY COLLECTED AT FINAL PACK WAS 45 PAIRS BEFORE INCREASING THE LOT SIZE, BUT THE REQUIRED QUANTITY WAS 38 PAIRS FOR SIZE 7.5. HENCE, FINAL PACK (SHIFT A) HAS 7 PAIRS EXCESS OF STRATIFIED SAMPLES, AND THE EXCESS STRATIFIED SAMPLES WERE NOT DISPOSED IMMEDIATELY. FINAL PACK HAS RETURNED THE EXCESS 7 PAIRS OF STRATIFIED SAMPLES TO PACKING LINE 3, WHILE THE LINE IS RUNNING LOT 23F4600, BIOGEL PI ULTRA TOUCH (SYNTHETIC), SIZE 7.5. RESPECTIVE PACKING PERSONNEL WAS NOT INFORMED ON THE RETURNED PACKS OR IDENTIFIED THE PACKS WITH LABEL OR INDICATION. AFTER PERFORMED TEAR OPEN ACTIVITY, EVENTUALLY THAT EXCESS STRATIFIED SAMPLES MIXED WITH CURRENT PRODUCTION RUN LOT 23F4600. CORRECTIVE ACTION(S)/PREVENTIVE ACTIONS(S): CORRECTIVE ACTION(S): REVIEW AND UPDATE THE CURRENT SOP ON THE AD HOC OF THE CHANGES OF THE PACKING LOT SIZE AND MANAGEMENT OF HANDLING STRATIFIED SAMPLE ACTIVITY. TO HAVE 4 TEAMS OF PACKING PERSONNEL TO HANDLE NR LATEX PRODUCT. THE PACKING ROOM WILL ONLY PACK NR GLOVES AT ONE TIME.

    Description of Event or Problem · 0

    A PHYSICIAN RETRIEVED A PACKAGE OF STERILE NON-LATEX GLOVES FOR A CARDIAC CATH PROCEDURE ON (B)(6) 2023. UPON OPENING THE GLOVES, IT WAS NOTICED THAT THE INNER PAPER PACKAGE WAS LABELED AS LATEX GLOVES WHICH DID NOT MATCH THE OUTER PACKAGE LABEL OF NON-LATEX. THE GLOVE SUPPLY WAS SEARCHED IN THE CATH LAB AND ONE ADDITIONAL PACKAGE WAS FOUND. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED DELAYS OR HARM. THE GLOVE SUPPLY ACROSS THE HOSPITAL WAS ASSESSED AND NO ADDITIONAL ABERRANT GLOVES WERE FOUND. SAMPLES HAVE BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS IN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98215 BIOGEL PI ULTRATOUCH KGO MOLNLYCKE HEALTH CARE 41175-00 23F4600

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other