BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW

    MDR report key: 19960407 · Received August 12, 2024

    Report

    Report Number
    1213809-2024-00533
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 10, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903043874
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) SUPPLEMENTAL MDR - NEEDLE BROKEN. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    MATERIAL#: 304387 BATCH NUMBER#: 3012230. IT WAS REPORTED THAT THE BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED SURGEON INSERTED HYPO NEEDLE INTO PATIENT'S CHEST TO INJECT LOCAL FOR SURGICAL INCISION. WHEN HE INSERTED THE HYPO, THE NEEDLE BROKE OFF WHILE USING IT ON THE PATIENT. NEEDLE AND OTHER PIECES WERE REMOVED AND NONE LEFT INSIDE PATIENT. (BF304387) LOT NUMBER - 3012230. PLEASE REVIEW THE CASE INFORMATION BELOW FOR A CUSTOMER REPORTED COMPLAINT FOR ONE OF YOUR PRODUCTS. THERE IS A SAMPLE AVAILABLE. COMPLAINT NUMBER, CREATED DATE, EVENT DATE, MANUFACTURING SITE, PRODUCT MALFUNCTION/FAILURE MODE. PRODUCT DESCRIPTION SUMMARY: COMPLAINT QUANTITY SAMPLE AVAILABLE RESOURCE COMPONENT # MFG. SKU NUMBER COMPONENT NAME INVESTIGATED COMPONENT LOT NUMBER WAS THERE AN INJURY WAS THERE A DEATH CASE (B)(4). ON (B)(6) 2024 BROKE SURGEON INSERTED HYPO NEEDLE INTO PATIENT'S CHEST TO INJECT LOCAL FOR SURGICAL INCISION. WHEN HE INSERTED THE HYPO, THE NEEDLE BROKE OFF WHILE USING IT ON THE PATIENT. NEEDLE AND OTHER PIECES WERE REMOVED AND NONE LEFT INSIDE PATIENT. (BF304387) 2 YES BF304387~PSPRMS 304387 NDL, HYPODERMIC,23GX1-1/2IN, RB, TW, SAFETYGLIDE, ST. 3012230 NO, NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935107 BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 3012230 30382903043874

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown