BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML S/T W/NDL 25X5/8 RB

    MDR report key: 18784149 · Received February 26, 2024

    Report

    Report Number
    1213809-2024-00115
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 7, 2024
    Report Date
    April 25, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096269
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWELVE SAMPLES AND THREE PHOTOS OF 1ML LUER-SLIP SYRINGES W/25X5/8" NEEDLES ATTACHED (MATERIAL #309626) WERE RECEIVED AND EVALUATED. THREE SYRINGE EACH FROM LOTS 2341837, 3048203, 3058292, & 3150938 WERE RECEIVED IN SEALED PACKAGES WITH ALL APPLICABLE PRODUCT INFORMATION ON THE TOP WEB. ALL 12 SAMPLES WERE TESTED FOR LEAKAGE AND FOUND ACCEPTABLE WITHOUT LEAKAGE. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. ONE OF THE PHOTOS SHOWS AN UNSEALED PACKAGE WITH APPLICABLE PRODUCT INFORMATION VISIBLE. ANOTHER PHOTO SHOWS A LOOSE NEEDLE WITH THE CANNULA BENT AND PUNCTURING THE SHIELD. THE NEXT IMAGE SHOWS A LOOSE SYRINGE WITH THE SCALE MARKINGS GROSSLY SKEWED AND PARTIALLY MISSING. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. THE REPORTED LEAKAGE DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. IT IS RECOMMENDED TO HAND TIGHTEN THE NEEDLE ONTO THE SYRINGE PRIOR TO USE. POTENTIAL ROOT CAUSE FOR THE SCALE MARKINGS DEFECTS IS ASSOCIATED WITH THE MARKING PROCESS. POTENTIAL ROOT CAUSE FOR THE NEEDLE THROUGH SHIELD DEFECT IS ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. THE PHOTOS WILL BE FORWARDED TO THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2341837, 3048203, 3058292, & 3150938 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL #: 309626 BATCH#: 3058292, 3150938, 2341837, 3048203.IT WAS REPORTED BY CUSTOMER THAT DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RE-STICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE. WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLES LAST MONTH LAST AND, IN THE FALL, NOT SURE OF THE DAYS. NURSES JUST CLEANED IT OFF AND COVERED. VERBATIM:RCC RECEIVED A COMPLAINT VIA MAIL. PIR ATTACHED. (B)(6) NURSEFAULTY SYRINGE MATERIAL 309626 LOT 3058292, 3150938, 2341837, 3048203DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RESTICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE.WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLESLAST MONTH LAST AND IN THE FALL NOT SURE OF THE DAYS.NURSES JUST CLEANED IT OFF AND COVERED. CUSTOMER DOES HAVE THE SAMPLES AVAILABLE FOR THE INVESTIGATION. THEY ORDER FROM CONCORDANCE HEALTH AND WOULD LIKE CREDIT FOR 20 BOXES, DOES NOT HAVE A PO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 25X5/8 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: "DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RE-STICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE. WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLES LAST MONTH LAST AND, IN THE FALL, NOT SURE OF THE DAYS. NURSES JUST CLEANED IT OFF AND COVERED. " (B)(6) FAULTY SYRINGE MATERIAL 309626 LOT 3058292, 3150938, 2341837, 3048203. DURING THE INJECT THE MEDICATION IS LEAKING FROM THE HUB SO THE PATIENTS ARE NOT GETTING THE FULL VACCINE. THEY ARE HAVING TO RESTICK THE PATIENTS TO MAKE SURE THEY GET THE VACCINE. WHEN THEY DRAW UP THE MEDICATION AND THEY HAVE TO RECAP THE NEEDLE, THEY HAVE HAD 2 NEEDLE STICKS DUE TO THE BEVEL PENETRATING THE CAP. 2 CLEAN NEEDLES LAST MONTH LAST AND IN THE FALL NOT SURE OF THE DAYS. NURSES JUST CLEANED IT OFF AND COVERED. CUSTOMER DOES HAVE THE SAMPLES AVAILABLE FOR THE INVESTIGATION. THEY ORDER FROM CONCORDANCE HEALTH AND WOULD LIKE CREDIT FOR 20 BOXES, DOES NOT HAVE A PO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628881 BD SYRINGE 1ML S/T W/NDL 25X5/8 RB SYRINGE, PISTON FMF BECTON DICKINSON MEDICAL SYSTEMS 3150938 30382903096269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown