BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB

    MDR report key: 10743691 · Received October 27, 2020

    Report

    Report Number
    1213809-2020-00751
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 12, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE LOOSE SAFETYGLIDE NEEDLE ASSEMBLY AND AN OPENED BLISTER PACK FROM BATCH 0232870 (P/N 305916) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THE CANNULA WAS SEPARATED FROM THE HUB, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE NEEDLE HUB SEPARATION DEFECT IS ASSOCIATED WITH THE NEEDLE MANUFACTURING PROCESS. THE SAMPLE WAS FORWARDED TO THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. VISUAL INSPECTION WAS PERFORMED UNDER A 30X MICROSCOPE. IT WAS IDENTIFIED THAT NOT ENOUGH EPOXY WAS APPLIED TO THE NEEDLE-PLASTIC HUB JOINT. DHR WAS PERFORMED. DURING THE INSPECTIONS AND TESTING PERFORMED WHILE PRODUCING THIS LOT, NO SIMILAR DEFECTS HAVE BEEN DOCUMENTED. PROBABLE ROOT CAUSE IS THAT A MACHINERY JAM OCCURRED, AND NO/ NOT ENOUGH EPOXY WAS APPLIED AT THE NEEDLE-NEEDLE HUB JOINT. BASED ON THE INVESTIGATION AND THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE SFTYGLD 25X1 RB DETACHED FROM THE HUB AND REMAINED IN THE PATIENT'S ARM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD AN ISSUE LAST WEEK HERE AT *OMITTED* WITH A BD NEEDLE. THE INFORMATION AS TO LOT NUMBER AND CATALOG NUMBER ARE ATTACHED. IT WAS A 25G 1"" NEEDLE AND THE ISSUE IS THAT THE NEEDLE CAME OFF AND STAYED IN THE PATIENT'S ARM."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE SFTYGLD 25X1 RB DETACHED FROM THE HUB AND REMAINED IN THE PATIENT'S ARM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD AN ISSUE LAST WEEK HERE AT *OMITTED* WITH A BD NEEDLE. THE INFORMATION AS TO LOT NUMBER AND CATALOG NUMBER ARE ATTACHED. IT WAS A 25G 1"" NEEDLE AND THE ISSUE IS THAT THE NEEDLE CAME OFF AND STAYED IN THE PATIENT'S ARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209579 NEEDLE SFTYGLD 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 0232870 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1