BEUDAMED
    FDA Adverse Event Other Summary report: N

    EBB BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM

    MDR report key: 3252672 · Received July 18, 2013

    Report

    Report Number
    3007532103-2013-00001
    Event Type
    Other
    Date Received
    July 18, 2013
    Manufacturer
    GLENVEIGH SURGICAL, LLC.
    Product Code
    OQY
    PMA / PMN Number
    091958
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NOTIFIED OF COMPLAINT ON (B)(4) 2013 VIA PHONE CALL TO CLINICAL SUPPORT STAFF. CLINICIAN RESPONDED TO COMPLAINT BY ATTEMPTING TO CONVINCE THE CUSTOMER THAT DEVICE STERILITY AND PERFORMANCE WERE GOOD THROUGH DATE INDICATED ON OUTERMOST LABEL, BUT CUSTOMER WAS NOT SATISFIED. CLINICIAN FORWARDED CONTACT INFORMATION TO GLENVEIGH QUALITY/OPERATIONS, WHO MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER, LEAVING VOICE MESSAGES EACH TIME. NONE OF GLENVEIGH'S ASSUMED COMPLAINANT WAS SATISFIED UNTIL RECEIPT OF MAUDE (B)(4) ON JUNE 12, 2013. PROBLEM: MULTIPLE LABELS WERE PRESENT ON THIS PRODUCT LOT DUE TO TWO EXTENSIONS OF SHELF-LIFE/EXPIRATION DATING, FIRST TO 24-MONTH SHELF-LIFE, AND LATER TO 36-MONTH SHELF-LIFE. PRIOR TO EACH OVER-LABELING, APPROPRIATE PACKAGING AND PERFORMANCE TESTING WAS SUCCESSFULLY COMPLETED AFTER ACCELERATED-AGING TO SIMULATE 24-MONTHS AND 36-MONTHS OF STORAGE, RESPECTIVELY. NEW LABELING IS DESIGNED TO ADHERE TIGHTLY AND COMPLETELY COVER OLD LABELS. HOWEVER, AS LABELS ARE AFFIXED TO CLEAR MYLAR, THE BACKS OF THE LABELS CAN BE SEEN THROUGH THE MYLAR. GLENVEIGH LABELING IS IN COMPLIANCE TO ALL GMPS AND CDRH GUIDANCE TITLED 'LABELING, REGULATORY REQUIREMENTS FOR MEDICAL DEVICES', AUGUST 1989. PROBLEM: MATTER OF CUSTOMER PREFERENCE ONLY. GLENVEIGH'S USE OF THE HOURGLASS SYMBOL AND DATE WITHOUT ENGLISH TEXT IS IN ACCORDANCE TO ISO15223-1:2012, SECTION 5.1.4. IN GLENVEIGH'S EVALUATION, NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    THIS DESCRIPTION IS TAKEN FROM THE USER FACILITY'S ACCOUNT OF THE ISSUE, DOCUMENTED IN MAUDE REPORT (B)(4). 'PROBLEM: PRODUCT HAS SEVERAL LABELS PLACED ON TOP OF EACH OTHER. WHEN THE LABELS ARE PEELED BACK, EACH LAYER OF LABEL HAVE DIFFERENT EXPIRATION DATES. PROBLEM: PRODUCT LABEL USES SYMBOL ONLY TO INDICATE EXPIRATION DATE WITHOUT THE PRINTED ENGLISH WORDS "EXPIRATION DATE."'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335198 EBB BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM BALLOON TAMPONADE CATHETER OQY GLENVEIGH SURGICAL, LLC. CTS-1000 97667

    Patients

    Seq Age Sex Outcome Treatment
    1