BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 20345462 · Received October 1, 2024

    Report

    Report Number
    1213809-2024-00681
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    July 26, 2024
    Report Date
    December 3, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010276
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBERS INCLUDE 4005103, 4096516 AND 4031039. OTHER EXPIRATION DATES INCLUDE 2028-12-31, 2029-03-31 AND 2029-01-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATES ARE 2024-01-05, 2024-04-05 AND 2024-01-31.

    Additional Manufacturer Narrative · 0

    (B)(4). - SUPPLEMENTAL MDR - LUER CRACKED / DAMAGED / DEFORMED. TWENTY SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL SAMPLES WERE RECEIVED LOOSE WITH THE TIP SLIGHTLY BENT; HOWEVER, IT DOES NOT INTERFERE WITH THE SEATING OF A NEEDLE BEING ATTACHED. THIS DOES NOT AFFECT FORM, FIT OR FUNCTION, THEREFORE ACCEPTABLE PER PRODUCT SPECIFICATION. SINCE THE CONDITION OBSERVED ARE CONSIDERED COSMETIC AND ACCEPTABLE, NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 4005103, 4096516, 4031039 AND 4171421. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS LUER WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM ITALIAN TO ENGLISH: GOOD AFTERNOON, IN ADDITION TO THE NON-COMPLIANCE IN QUESTION, WE FIND OURSELVES AGAIN REPORTING THE "CROOKED LUER" IN CODE 301027 SYRINGES. THE IDENTIFICATION OF THE BATCH IS DIFFICULT AS SEVERAL BATCHES HAVE BEEN USED IN PRODUCTION, AS FOLLOWS: LOTTO SIDAM, SUPPLIER LOT (BD): CF01529 , 400513; CF02167 , 4096516; CF02566 , 4031039; CF02739 , 4171421. THE QUANTITIES REJECTED ARE (B)(4) PIECES. WE ASK FOR FEEDBACK AS SOON AS POSSIBLE AS THE QUANTITIES OF WASTE ARE CONSIDERABLE. THANK YOU. ON (B)(4) 2024 DURING PRODUCTION, TWO ISSUES WERE FOUND DURING CHECK ON PART NUMBER 301027, 5 ML SYRINGE S/NEEDLE CONE LUER LOCK BULK. THE FIRST DEFECT FOUND CONCERNS A LINE OF INK BELOW THE MEASURING MARKS, AS SHOWN IN THE PHOTO BELOW (DEFECT HIGHLIGHTED IN RED): THE SECOND DEFECT FOUND CONCERNS THE SYRINGE LUER, WHICH IS CROOKED, THIS DEFECT IN TURN RESULTS IN A FURTHER MISALIGNMENT BETWEEN THE SYRINGE/CONNECTOR CONNECTION, SEE PHOTO BELOW: ON 11/09/2024, JOB ORDER (B)(4) WE ARE REPORTING (B)(4) PIECES OF SCRAP FOR THE ¿CROOKED LUER¿. LOT IDENTIFICATION IS DIFFICULT AS PIT LOTS HAVE BEEN USED IN PRODUCTION, BELOW ARE THOSE INVOLVED:

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41115 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4171421 50382903010276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown