BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 22X1-1/2 RB

    MDR report key: 9779369 · Received March 3, 2020

    Report

    Report Number
    1213809-2020-00151
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 10, 2020
    Report Date
    March 27, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059004
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6.INVESTIGATION SUMMARY ONE PHOTO OF A LOOSE SAFETYGLIDE NEEDLE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS NO SAFETY SHIELD PRESENT AND THE CANNULA WAS SEPARATED FROM THE HUB. IT APPEARED THERE WAS INSUFFICIENT EPOXY ON THE CANNULA, WHICH WAS REJECT PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE CANNULA SEPARATION DEFECT IS ASSOCIATED WITH THE SAFETYGLIDE NEEDLE ASSEMBLY PROCESS. WHEN THE NEEDLE WAS ASSEMBLED TO THE PLASTIC HUB NO EPOXY WAS APPLIED; THE NEEDLE WAS BEEN HOLD BY THE SAFETY MECHANISM. WHEN THE SAFETY MECHANISM GOT ACTIVATED THE NEEDLE GOT LOOSE. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 7212757 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. 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 THAT NEEDLE SFTYGLD 22X1-1/2 RB CANNULA BROKE OFF FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305900 BATCH NO.: 7212757 IT WAS REPORTED THE NEEDLE BROKE OFF FROM THE HUB.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE SFTYGLD 22X1-1/2 RB CANNULA BROKE OFF FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305900 BATCH NO.: 7212757. IT WAS REPORTED THE NEEDLE BROKE OFF FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246553 NEEDLE SFTYGLD 22X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305900 7212757 30382903059004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other