BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 16441915 · Received February 27, 2023

    Report

    Report Number
    3003639970-2023-00048
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    November 30, 2022
    Report Date
    February 27, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME & MODEL #: TWO POSSIBLE PRODUCTS: SAFIL UNDYED 4/0 (1,5) 45CM DS19 (M) (MODEL NUMBER C1049220); SAFIL VIOLET 3/0(2)4X45CM HR22 TO(M) (MODEL NUMBER C1078730). 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: K031286 ANALYSIS AND RESULTS: ACCORDING TO THE INFORMATION CONTAINED IN THE CFDA REPORT: SAFIL CFDA REGISTRATION CERT NO.; MANUFACTURING DATE: 21.08.2018. ONLY TWO CODE-BATCHES ARE POSSIBLE (WITH DISTRIBUTION TO CHINA): C1049220 - 718342; C1078730 - 718342. THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE TWO POSSIBLE CODE-BATCHES. C1049220 - SAFIL UNDYED 4/0 45CM DS19; BATCH 718342. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. C1078730 - SAFIL VIOLET 3/0 4X45CM HR22 TO; BATCH 718342. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. NO SAMPLES RECEIVED FROM THE CUSTOMER. WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. REVIEWED THE BATCH MANUFACTURING RECORDS OF BOTH CODE-BATCHES, THESE PRODUCTS HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH SAFIL SUTURE. THE CLIENT REPORTED THAT THE PATIENT UNDERWENT TENSION-FREE REPAIR OF RIGHT INGUINAL HERNIA. DURING THE FOURTH OPERATION AT 07:30 ON (B)(6) 2022, THE SUTURE WAS OPENED AND IT WAS FOUND THAT THERE WAS NO NEEDLE INSIDE. ANOTHER SUTURE WAS USED AGAIN, RESULTING IN PROLONGED OPERATION TIME AND WASTE OF CONSUMABLES. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398835 SEE H10 SYNTHETIC ABSORBABLE BRAIDED SUTURE GAM B. BRAUN SURGICAL, S.A. SEE H10 718342

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male