BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 1 (4) 8X45CM HRB48 TO(M)

    MDR report key: 16911179 · Received May 11, 2023

    Report

    Report Number
    3003639970-2023-00126
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 11, 2023
    Report Date
    June 30, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    NEW
    PMA / PMN Number
    K031216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: EXACT BATCH NUMBER IS UNKNOWN. TWO POSSIBLE BATCHES: 122295 AND 122285. THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE TWO POSSIBLE BATCHES. THERE ARE NO UNITS IN STOCK OF ANY OF THE TWO POSSIBLE BATCHES. SAMPLES RECEIVED 1 OPEN UNUSED TD PACK (5 DETACHED NEEDLES AND 3 SUTURES WITH NEEDLE). ALSO RECEIVED FROM END CUSTOMER: 6 CLOSED TD PACKS OF BATCH 122295 AND 4 CLOSED TD PACKS OF BATCH 122285. WE HAVE RECEIVED AN OPEN SAMPLE OF BATCH UNKNOWN WITH 3 THREADS ATTACHED TO THE NEEDLE. NEEDLE ATTACHMENT RESULTS CONDUCTED ON THE SAMPLES RECEIVED OF UNKNOWN BATCH ARE 0.258 KGF FOR MINIMUM AND 0.343 KGF FOR MAXIMUM AND FULFIL B. BRAUN SURGICAL REQUIREMENTS: 0.080<XI<1.590 KGF. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 252 UNITS OF THIS CODE OF BATCH 122285. WE HAVE RECEIVED 4 CLOSED SAMPLES. NEEDLE ATTACHMENT RESULTS CONDUCTED ON THE SAMPLES RECEIVED OF BATCH 122285 ARE 0.106 KGF FOR MINIMUM AND 0.798 KGF FOR MAXIMUM AND FULFIL B. BRAUN SURGICAL REQUIREMENTS: 0.080<XI<1.590 KGF. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE OF BATCH 122295. WE HAVE RECEIVED 6 CLOSED SAMPLES. NEEDLE ATTACHMENT RESULTS CONDUCTED ON THE SAMPLES RECEIVED OF BATCH 122295 ARE 0.210 KGF FOR MINIMUM AND 0.823 KGF FOR MAXIMUM AND FULFIL B. BRAUN SURGICAL REQUIREMENTS: 0.080<XI<1.590 KGF. REVIEWED BATCH MANUFACTURING RECORDS, BOTH BATCHES HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE SAMPLES 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.

    Additional Manufacturer Narrative · 0

    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 THERE IS NO PATIENT USE BECAUSE THE NEEDLE AND THREAD JOINT CAME OFF BEFORE PATIENT USE. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863702 MONOPLUS VIOLET 1 (4) 8X45CM HRB48 TO(M) SYNTHETIC ABSORBABLE MONOFILAR SUTURES NEW B. BRAUN SURGICAL, S.A. M0024876

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown