BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 4/0 (1.5) 45CM DS16

    MDR report key: 14727047 · Received June 17, 2022

    Report

    Report Number
    3003639970-2022-00255
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 20, 2022
    Report Date
    July 25, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAR
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: K151165. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED A PICTURE OF A PRODUCT BOX IN WHICH THE PRE-PRINTED BOX CORRESPONDS TO DAFILON AND THE BOX LABEL CORRESPONDS TO A SUPRAMID REFERENCE-BATCH (CODE G0712132; SUPRAMID BLACK 4/0 (1.5) 45CM DS16 AND BATCH 622036). NO FURTHER INFORMATION HAS BEEN RECEIVED ABOUT THE PRODUCT THAT CONTAINS THE BOX. HOWEVER, IT IS MOST LIKELY THAT THE LABEL ON THE BOX AND THE PRODUCT MATCH (SUPRAMID), BUT THE PRE-PRINTED BOX IS WRONG (DAFILON). THIS MISTAKE TOOK PLACE AT THE MOMENT OF SELECTION OF PRE-PRINTED BOX OF THE PRODUCT IN THE WAREHOUSE. THE PERSON WHO WAS CONDITIONING THE PRODUCT, SELECTED A WRONG PRE-PRINTED BOX AND DID NOT NOTICE THAT. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE PICTURE RECEIVED SHOWS A PRODUCT BOX THAT DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE PICTURE 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. ON THE OTHER HAND, WAREHOUSE STAFF HAVE RECENTLY WORKED ON CORRECTING THIS TYPE OF INCIDENT. CONTROL MECHANISMS IN WAREHOUSE HAVE BEEN IMPLEMENTED TO AVOID THIS ISSUE IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH SUPRAMID SUTURE. THE CLIENT REPORTED THAT THEY RECEIVED TWO BOXES OF THE SAME CODE (G0712132) BUT LABELED WITH DIFFERENT PRODUCTS, IN ONE IT IS WRITTEN PRODUCT "SUPRAMID" AND IN THE OTHER ONE "DAFILON". MORE INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145029 SUPRAMID BLACK 4/0 (1.5) 45CM DS16 OTHER SUTURE GAR B. BRAUN SURGICAL, S.A. G0712132 622036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown