BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER SLIP TIP SYRINGE

    MDR report key: 15314985 · Received August 29, 2022

    Report

    Report Number
    1213809-2022-00524
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    August 3, 2022
    Report Date
    September 15, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096269
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL: YES. D.10. RETURNED TO MANUFACTURER ON: 31-AUG-2022. D.4. MEDICAL DEVICE LOT #: 2070981. D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027. H.4. DEVICE MANUFACTURE DATE: 11-MAR-2022. D.4. MEDICAL DEVICE LOT #: 2042951. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. H.4. DEVICE MANUFACTURE DATE: 11-FEB-2022. H.6. INVESTIGATION SUMMARY: FOURTEEN SAMPLES FROM LOT NUMBER 2042951 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL SAMPLES WERE VISUALLY EVALUATED UNDER THE 30X MICROSCOPE. NO DAMAGE, DEFECTIVE GRIND OR HOOKS WERE OBSERVED. THE BEVELS AND ETCH WERE GOOD. FIVE SAMPLES WERE OBSERVED TO HAVE DIFFICULT PLUNGER ROD MOVEMENT. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW. POTENTIAL ROOT CAUSE FOR THE INSUFFICIENT SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY SO NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2042951. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ LUER SLIP TIP SYRINGE EXPERIENCED THE PLUNGER NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER DOES NOT WORK WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ LUER SLIP TIP SYRINGE EXPERIENCED THE PLUNGER NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER DOES NOT WORK WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089212 BD¿ LUER SLIP TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309626 SEE H.10. 30382903096269

    Patients

    Seq Age Sex Outcome Treatment
    1 Female