BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIST S.Q+.U.2/0140CM HR37S/HS37S(M)DDP

    MDR report key: 5619437 · Received April 29, 2016

    Report

    Report Number
    2916714-2016-00301
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Date of Event
    February 24, 2016
    Report Date
    July 28, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE REGISTERED WITHIN THE U.S. (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: INDIA. SUTURES NEEDLE ARE BLUNT.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 OPEN AND 4 CLOSED POUCHES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. (B)(4) UNITS OF THIS CODE BATCH WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET, THERE ARE NO UNITS IN STOCK. RECEIVED FOUR CLOSED UNITS AND AN OPEN UNUSED SAMPLE. THE OPEN UNIT HAD TWO HS37S NEEDLES CONNECTED TO THE THREAD INSTEAD OF ONE HR37S AND ONE HS37S. THREAD CORRESPONDED TO A SAFIL QUICK UNDYED, USP 2/0 AND 140 CM LONG. THE CLOSED SAMPLES RECEIVED WERE ACCORDING TO THE PRODUCT DESCRIPTION (SAFIL QUICK UNDYED, 2/0 USP SIZE, 140CM LONG AND ONE HR37S AND ONE HS37S NEEDLES). TAKING INTO ACCOUNT THAT NO OTHER CUSTOMER COMPLAINTS HAVE BEEN RECEIVED FOR THIS CODE BATCH, IT IS CONSIDERED THAT THIS IS AN ISOLATED UNIT. HUMAN ERROR IS A HIGHLY PROBABLE CAUSE OF THE MISTAKE AND ONLY ONE SUTURE IS EXPECTED TO BE AFFECTED. REGARDING NEEDLE BLUNT COMPLAINT, PUNCTURE TEST RESULTS PERFORMED TO THE HR37S NEEDLES ARE: 0.428 N IN MAXIMUM IN THE FIRST PUNCTION; PRODUCT SPECIFICATIONS INDICATES THAT THE RESULTS ARE TO BE < 0.44 N. PUNCTURE TEST RESULTS OF THE HHS37S NEEDLES ARE: 0.676 N IN MAXIMUM IN THE FIRST PUNCTION; PRODUCT SPECIFICATIONS INDICATES THAT THE RESULTS ARE TO BE < 0.74 N. BOTH NEEDLES FULFILL THE CURRENT SPECIFICATIONS OF PUNCTURE STRENGTH. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL THE OEM REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFILL THE SPECIFICATIONS OF THE OEM, IT IS CONCLUDED THAT THE COMPLAINT IS JUSTIFIED. CORRECTIVE/PREVENTIVE ACTIONS: A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN OPENED IN ORDER TO DETERMINE ROOT CAUSE AND ACTIONS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276806 EPIST S.Q+.U.2/0140CM HR37S/HS37S(M)DDP SUTURES GAM B.BRAUN SURGICAL SA C1046913 114293

    Patients

    Seq Age Sex Outcome Treatment
    1 Other