BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMEND MAX 0 27" (70CM) HS26S VPL RCP

    MDR report key: 15800186 · Received November 15, 2022

    Report

    Report Number
    3003639970-2022-00470
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Report Date
    January 13, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D8: CORRECITON: YES. G2: CORRECTION: DISTRIBUTOR/IMPORTER. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. 324 UNITS OF THIS CODE BATCH WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. WE HAVE RECEIVED PICTURES SHOWING THAT THE EXPIRY DATE IN THE BOXES IS NOT VISIBLE OR IT IS PARTIALLY VISIBLE. AFTER AN EXHAUSTIVE INVESTIGATION THE ROOT CAUSE HAS BEEN DETERMINED A DISPLACEMENT OF THE POSITIONING OF THE LABELS VERSUS THE RIBBON IN THE PRINTING MACHINE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE PICTURES RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE PICTURES RECEIVED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, IT HAS BEEN DECIDED THAT PEGASUS ORDERS ARE SEPARATED FROM THE REST OF LABELING ORDERS TO MAKE SURE THAT THE LABELS ARE CORRECTLY PLACED IN THE PRINTING MACHINE IN ORDER TO AVOID THIS KIND OF DEFECTS. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: REGARDING THE AFFECTED MATERIAL, WE WILL RE-WORK IT IN OUR FACILITIES AND SEND THE PRODUCT CORRECTLY LABELED TO YOU.

    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 OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. UNDER PMA/510(K) NUMBER: K031216. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOMEND MAX SUTURE. THE CLIENT REPORTED THAT THE SUTURES WERE REJECTED FROM THE LAST SHIPMENT DUE TO THE EXPIRATION DATE WAS NOT VISIBLE. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2705057 MONOMEND MAX 0 27" (70CM) HS26S VPL RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE NEW B. BRAUN SURGICAL, S.A. 100523589 122246

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown