BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 8934935 · Received August 27, 2019

    Report

    Report Number
    1213809-2019-00864
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    August 9, 2019
    Report Date
    August 19, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059035
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA/510(K)#: K980580(SYRINGE) K951254(NEEDLE). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. INVESTIGATION CONCLUSION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    MATERIAL NO.: 305903, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE THE SAFETY MECHANISM IS DIFFICULT TO ENGAGE. THIS OCCURRED ON 4 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAFETY MECHANISM IS DIFFICULT TO ENGAGE REQUIRING PEOPLE TO REPORT NEAR MISSES (WHEN ENGAGING THE SAFETY, THE NEEDLE CAN EASILY COME APART FROM THE SYRINGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731838 BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other