BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE

    MDR report key: 8287379 · Received January 29, 2019

    Report

    Report Number
    1213809-2019-00129
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    December 13, 2018
    Report Date
    April 26, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903059240
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE 3ML SYRINGE WITH SAFETYGLIDE NEEDLE IN AN OPEN BLISTER PACK FROM BATCH #6090858 (P/N 305924) WAS RECEIVED AND VISUALLY EVALUATED. THE SYRINGE CONTAINED CLEAR RESIDUE DROPLETS AND THE SAFETY SHIELD WAS DEPLOYED. INITIALLY, IT WAS OBSERVED THE STOPPER APPEARED TO NOT BE SEATED PROPERLY ON THE END OF THE PLUNGER ROD. AFTER THE PLUNGER ROD WAS REMOVED FROM THE SYRINGE AND THE STOPPER WAS TAKEN OFF THE PLUNGER ROD, IT WAS OBSERVED THE END OF THE PLUNGER ROD WAS BENT. POTENTIAL ROOT CAUSE FOR THE LEAKAGE PAST STOPPER DEFECT IS ASSOCIATED WITH THE DAMAGED PLUNGER ROD. THE END OF THE PLUNGER ROD WAS BENT WHICH PREVENTED THE STOPPER FROM BEING SEATED PROPERLY. THE DAMAGE TO THE PLUNGER ROD OCCURRED DURING THE ASSEMBLY OR MATERIAL HANDLING PROCESS. 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

    IT WAS REPORTED THAT DURING USE OF A BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE LEAKED AROUND THE PLUNGER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF A BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE LEAKED AROUND THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79017 BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 6090858 30382903059240

    Patients

    Seq Age Sex Outcome Treatment
    1 Other