BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 17785768 · Received September 20, 2023

    Report

    Report Number
    1213809-2023-01046
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    July 28, 2023
    Report Date
    October 17, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 16-OCT-2023. ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE PRINTED SCALE WAS ENTIRELY MISSING FROM THE SYRINGE BARREL. A SMALL SPATTER OF INK COULD BE SEEN ON THE BARREL NEAR ONE OF THE FLANGES. UPON FURTHER EVALUATION A VERY MINOR AMOUNT OF CONTACT DAMAGE COULD BE SEEN ON ONE OF THE BARREL FLANGES NOT AFFECTING FUNCTION. THE MISSING PRINT CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THESE DEFECTS ARE OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP HAD SCALE MARKING ISSUES. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE FACT IS THAT THE SYRINGE HAS NOT PRINT SCALE ON ITS BODY. DESCRIPTION OF THE DEFICIENCY: THE CUSTOMER REPORTED THE SCALE WAS NOT PRINTED ON THE SYRINGE. VISUAL EXAMINATION OF THE RETURNED SYRINGE REVEALED THE SYRINGE APPEARS TO BE A 10ML INJECTION SYRINGE LUER-SLIP (K-01000-023A). HOWEVER, THE PRINTED SCALE APPEARS TO BE MISSING ON THE BARREL (REFERENCE ATTACHED FILES ANP20046654). NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP HAD SCALE MARKING ISSUES. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE FACT IS THAT THE SYRINGE HAS NOT PRINT SCALE ON ITS BODY. DESCRIPTION OF THE DEFICIENCY: THE CUSTOMER REPORTED THE SCALE WAS NOT PRINTED ON THE SYRINGE. VISUAL EXAMINATION OF THE RETURNED SYRINGE REVEALED THE SYRINGE APPEARS TO BE A 10ML INJECTION SYRINGE LUER-SLIP (K-01000-023A). HOWEVER, THE PRINTED SCALE APPEARS TO BE MISSING ON THE BARREL (REFERENCE ATTACHED FILES ANP20046654). NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614782 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1025005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown