BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 3/0(2)8X45CM HR26 TO (M)

    MDR report key: 5494713 · Received March 11, 2016

    Report

    Report Number
    2916714-2016-00187
    Event Type
    Malfunction
    Date Received
    March 11, 2016
    Date of Event
    January 29, 2016
    Report Date
    May 24, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: NONE. ANALYSIS AND RESULTS: LIST OF BATCHES OF THIS REFERENCE SUPPLIED TO THE END CUSTOMER IN 2016: 115245, 115262, 115112, 115123 AND 115405. REVIEW OF EACH OF THE BATCH MANUFACTURING RECORDS OF THE FIVE BATCHES SUPPLIED TO THE CUSTOMER IN 2016 WAS COMPLETED AND ALL HAD A NORMAL PROCESS, ALL MET PRODUCT REQUIREMENTS. BATCH 115245: (B)(4) UNITS MANUFACTURED AND DISTRIBUTED. THERE ARE NO UNITS IN STOCK. BATCH 115262: (B)(4) UNITS MANUFACTURED AND DISTRIBUTED. THERE ARE NO UNITS IN STOCK. BATCH 115112: (B)(4) UNITS MANUFACTURED AND DISTRIBUTED. THERE ARE NO UNITS IN STOCK. BATCH 115123: (B)(4) UNITS MANUFACTURED AND DISTRIBUTED. THERE ARE NO UNITS IN STOCK. BATCH 115405: (B)(4) UNITS MANUFACTURED AND DISTRIBUTED. THERE ARE NO UNITS IN STOCK. WITHOUT ANY SAMPLE OR PICTURE SHOWING THE DEFECT, A COMPLETE ANALYSIS IS NOT POSSIBLE. FINAL CONCLUSION: WITHOUT SAMPLES THERE IS NO POSSIBILITY OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFILL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: THERE IS A CAPA OPEN RELATED TO THE DEFECT DESCRIBED IN THIS COMPLAINT. THIS COMPLAINT IS INCLUDED IN THIS CAPA, THE POSSIBLE BATCHES INVOLVED WERE MANUFACTURED PREVIOUS TO THE IMPLEMENTATION OF THE DIFFERENT ACTIONS.

    Additional Manufacturer Narrative · 1

    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. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). WHEN THE CUSTOMER USED THE PRODUCT IN SURGERY, HE FOUND THE 1 SUTURE WAS MISSING. AFTER SEEKING THE MISSING SUTURE, THE CUSTOMER FINALLY NOTICED THAT THE FOAM OF THE PACKAGE SHOWS NO SUTURE WAS PACKED. THIS PRODUCT SHOULD HAVE 8 SUTURES, BUT THE CUSTOMER ASSUMED THAT THIS PRODUCT HAD ONLY 7 SUTURES IN A PACKAGE. REASON FOR VIGILANCE SUSPICIOUS: DUE TO THE MISSING NEEDLE, THE HOSPITAL STAFFS HAD TO SEARCH FOR IT IN A OPERATION ROOM AND THE OPERATIVE FIELD DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150497 SAFIL VIOLET 3/0(2)8X45CM HR26 TO (M) SUTURES GAM B.BRAUN SURGICAL SA M1078171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other