BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 1(4)150CM HRC40S LOOP(M)

    MDR report key: 19050892 · Received April 5, 2024

    Report

    Report Number
    3003639970-2024-00134
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Report Date
    April 5, 2024
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    NEW
    PMA / PMN Number
    K031216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: THE INVOLVED BATCH IS NOT KNOWN. THE POSSIBLE BATCHES ARE: 123235, 123441, 123393, 123341, 123363, 123292, 122454 AND 123171. THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE POSSIBLE BATCHES. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THE BATCH 122454, (B)(4) UNITS OF THE BATCH 123171, (B)(4) UNITS OF THE BATCH 123235, (B)(4) UNITS OF THE BATCH 123292, (B)(4) UNITS OF THE BATCH 123341, (B)(4) UNITS OF THE BATCH 123363, (B)(4) UNITS OF THE BATCH 123393 AND (B)(4) UNITS OF THE BATCH 123441. THERE ARE NO UNITS IN STOCK OF ANY OF THE POSSIBLE REPORTED BATCHES. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORDS, THERE ARE NO INCIDENCES RELATED TO THIS ISSUE AND ALL POSSIBLE BATCHES WERE RELEASED FULFILLING USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE AS NO CLOSED SAMPLES HAVE BEEN RECEIVED FOR ANALYSIS. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE POSSIBLE AFFECTED PRODUCTS DO 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. HOWEVER, ACCORDING TO THE BATCH MANUFACTURING RECORDS REVIEW, THE POSSIBLE PRODUCTS COMPLY WITH OUR SPECIFICATIONS; THEREFORE, WE DO NOT SEE ANY MANUFACTURING FAULT OR MATERIAL DEFECT THAT COULD HAVE CAUSED THE INCIDENCE. CORRECTIVE MEASURES: 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 MONOPLUS SUTURE. THE CLIENT REPORTED A RECENT INCIDENT WHERE A PATIENT SUFFERED A COMPLETE WOUND DEHISCENCE FOLLOWING A SNAPPED MONOPLUS LOOP PDS SUTURE IN A CAESAREAN WOUND. THE REFERENCE NUMBER FOR THE PRODUCT IS (B)(4). WE JUST WANTED TO CONTACT AND INFORM YOU SO YOU CAN KEEP RECORD IN THE CASE THAT THERE WERE ANY OTHER REPORTED FAULTS. UNFORTUNATELY, THE LOT NUMBER WAS NOT RECORDED SO I CANNOT GIVE YOU THAT. 1. ONLY PATIENT HARM WAS THE NEED TO RETURN TO THEATRE TO HAVE THE WOUND RE-REPAIRED. NO INFECTION OR OTHER CONCERNS. 2. CAESAREAN SECTION 3. NO DELAY TO THE PROCEDURE 4. NO SAMPLE AVAILABLE. WE HAVE HAD AN UPDATE FROM THE CUSTOMER TO CONFIRM THEY CANNOT SHARE ANY FURTHER INFORMATION OTHER THAN WHAT HAS BEEN PROVIDED WITHOUT CONSENT. THEY HAVE ALSO CONFIRMED THAT THEY DID NOT WANT TO RAISE THIS AS A COMPLAINT, IT WAS JUST FOR FEEDBACK. POSSIBLE BATCHES: 123235, 123441, 123393, 123341, 123363, 123292, 122454 OR 123171. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86895 MONOPLUS VIOLET 1(4)150CM HRC40S LOOP(M) SYNTHETIC ABSORBABLE MONOFILAR SUTURE NEW B. BRAUN SURGICAL, S.A. B0024739

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female