BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 0 (3,5) 90CM HR37S(M)RCP

    MDR report key: 13000379 · Received December 14, 2021

    Report

    Report Number
    3003639970-2021-00632
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Report Date
    January 19, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.U.
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. NEEDLE ATTACHMENT STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 2.46 KGF IN AVERAGE AND 1.54 KGF IN MINIMUM AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP REQUIREMENTS: 1.53 KGF IN AVERAGE AND 0.46 KGF IN MINIMUM). FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED. 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.

    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., 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 MONOPLUS SUTURE. THE CLIENT REPORTED THAT THE NEEDLE IS NOT ATTACHED TO THE THREAD. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902651 MONOPLUS VIOLET 0 (3,5) 90CM HR37S(M)RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE NEW B. BRAUN SURGICAL, S.A.U. C2024452 121015
    1902652 MONOPLUS VIOLET 0 (3,5) 90CM HR37S(M)RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE NEW B. BRAUN SURGICAL, S.A.U. C2024452 121015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown