BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD SAFETYGLIDE INSULIN SYRINGE

    MDR report key: 8957221 · Received September 3, 2019

    Report

    Report Number
    1213809-2019-00882
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 15, 2019
    Report Date
    September 20, 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
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO AND ONE 1ML SYRINGE IN A FULLY SEALED BLISTER PACK CONFIRMED TO BE FROM BATCH 8355914 (P/N 305903) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS AN ADDITIONAL NEEDLE WITHOUT A SHIELD IN THE BLISTER PACK. THE EXTRA COMPONENT IS REJECTABLE PER PRODUCT SPECIFICATION. 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. POTENTIAL ROOT CAUSE FOR THE EXTRA COMPONENT DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8355914 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE CAME WITH MULTIPLE UNITS IN THE PACKAGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SERIOUSLY PARALYZED, MORE THAN ONE NEEDLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL DEVICE TYPE: FMI (NEEDLE). ADDITIONAL COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE PMA/510(K)#: K980580(SYRINGE) K951254(NEEDLE).. 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 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE CAME WITH MULTIPLE UNITS IN THE PACKAGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SERIOUSLY PARALYZED, MORE THAN ONE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749498 1 ML BD SAFETYGLIDE INSULIN SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8355914 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other