BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLACK 3/0 (2) 100M

    MDR report key: 16041616 · Received December 23, 2022

    Report

    Report Number
    3003639970-2022-00554
    Event Type
    Malfunction
    Date Received
    December 23, 2022
    Date of Event
    July 6, 2022
    Report Date
    December 23, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. UNDER PMA/510(K) NUMBER: K990089. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 15 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED SOME PICTURES AND A VIDEO SHOWING A PRODUCT BOX OF THE REFERENCE F1134043 (SILKAM BLACK 3/0 (2) 100M) AND BATCH 619193 THAT CONTAINS A CASSETTE OF SILKAM WHITE 5 25M (CODE-BATCH F1124110-619181 ACCORDING TO THE INFORMATION RECEIVED). UPON INVESTIGATION, IT HAS BEEN DETERMINED THAT A MIX-UP OCCURRED DURING REWORK, AS BOTH PRODUCTS WERE PRODUCED AND PACKAGED ON TWO DIFFERENT DATES AND TIMES. A SILKAM WHITE USP 5 CASSETTE WAS MISTAKENLY INCLUDED IN A BOX LABELLED SILKAM BLACK USP 3/0, AND THE OPERATOR OVERLOOKED OR DID NOT CORRECTLY VERIFY THE CASSETTE WITH THE BOX DESCRIPTION. REVIEWED THE BATCH MANUFACTURING RECORD, THERE WAS A NON-CONFORMITY REGARDING THE SAME ISSUE. REMARKS: THE PERSONNEL INVOLVED WILL BE INFORMED OF THIS ISSUE AND A RE-TRAINING WILL BE GIVEN. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE SAMPLE RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE PICTURES AND VIDEO RECEIVED. 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: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE. MOREOVER, A RETRAINING AND AWARENESS WILL BE GIVEN TO THE INVOLVED PERSONNEL ABOUT THIS INCIDENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH SILKAM SUTURE (CASSETTE). THE CLIENT (VETERINARIAN) REPORTED THAT THE BOX RECEIVED MATCHED WITH THEIR REQUEST (SILKAM BLACK 3/0 100M BBRAUN), BUT THE CONTENT INSIDE WAS SILKAM WHITE 5 25M BBRAUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2748759 SILK BLACK 3/0 (2) 100M OTHER SUTURES (SILKAM CASSETTES) GAP B. BRAUN SURGICAL, S.A. F1134043 619193

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown