BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 27 G

    MDR report key: 16773121 · Received April 19, 2023

    Report

    Report Number
    1213809-2023-00385
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 29, 2023
    Report Date
    July 22, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096237
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIRTY-NINE SAMPLES AND FOUR PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. EACH SAMPLE EXPELLED THE SOLUTION WITH NORMAL FLOW, CLOGGED NEEDLE WAS NOT CONFIRMED. UPON EXAMINATION OF THE RETURNED PHOTO, IT WAS OBSERVED THAT SYRINGE HAS DOUBLE NEEDLE. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM OCCURRED AT THE CANNULATOR AND NOT DETECTED IN THE NEXT PROCESSES. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2131736. 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 WHILE USING BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 27 G THE NEEDLE WAS CLOGGED. THIS 1 OF 2 RELATED REPORTS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM A VALUE ANALYST FOR (B)(6). WE HAVE END USERS WHO ARE SEEING SAFETY ISSUES WITH ITEM 309623, 1CC 27GA SYRINGE WITH NEEDLES, LOT 2131736. THE ISSUES RANGE FROM PLUGGED NEEDLES TO BENT NEEDLES STICKING OUT OF THE SAFETY CAP/PACKAGING POSING A RISK FOR NEEDLE STICKS. THEY HAVE AROUND 100 EACH OF THE AFFECTED ITEM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935564 BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 27 G PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2131736 00382903096237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown