BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SF SAF QUI+ UNDY 4/0 (1,5) 70 CM DS16 (M)

    MDR report key: 3812601 · Received April 17, 2014

    Report

    Report Number
    2916714-2014-00273
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAM
    PMA / PMN Number
    K031286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFG SITE EVALUATION: SAMPLES RECEIVED: ONE UNOPENED POUCH. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. THE PACK RECEIVED IS TIGHT. WITH ONLY ONE SAMPLE RECEIVED WE CAN NOT CARRY OUT A PROPER ANALYSIS ON THE KNOT SECURITY TEST (WE NEED AT LEAST 10 SAMPLES TO DO A PROPER ANALYSIS). TESTED THE KNOT SECURITY CONTROL OF THE SAMPLE RECEIVED AND THE RESULTS ARE WITHIN SPECIFICATION. REVIEWED THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLIANT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE THREAD RELEASES AUTOMATICALLY, ALTHOUGH IT HAS BEEN KNOTTED 4 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236637 SF SAF QUI+ UNDY 4/0 (1,5) 70 CM DS16 (M) SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL S.A. C1046213S 110415

    Patients

    Seq Age Sex Outcome Treatment
    1 Other