BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8425365 · Received March 15, 2019

    Report

    Report Number
    2134319-2019-00102
    Event Type
    Malfunction
    Date Received
    March 15, 2019
    Date of Event
    February 4, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION. WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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

    IT WAS REPORTED THAT A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP HAD A DIFFICULT PLUNGER. THE REPORT IS AS FOLLOWS, " CUSTOMER REPORTED HE WAS UNABLE TO LOAD INSULIN INTO THE SYRINGE AS WHEN CUSTOMER PULLED BACK ON PLUNGED HE EXPERIENCED RESISTANCE. CUSTOMER DID NOT ALLEGE ANY ISSUE WITH CARTRIDGE OR NEEDLE AS HE STATED ISSUE WAS WITH SYRINGE AS ISSUE BEGAN WHEN NEEDLE WAS NOT ATTACHED TO SYRINGE HE EXPERIENCED RESISTANCE WHEN PULLING THE PLUNGER BACK AND THEN WHEN NEEDLE WAS ATTACHED ISSUE PERSISTED."

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K151766, K980987. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP HAD A DIFFICULT PLUNGER. THE REPORT IS AS FOLLOWS, " CUSTOMER REPORTED HE WAS UNABLE TO LOAD INSULIN INTO THE SYRINGE AS WHEN CUSTOMER PULLED BACK ON PLUNGED HE EXPERIENCED RESISTANCE. CUSTOMER DID NOT ALLEGE ANY ISSUE WITH CARTRIDGE OR NEEDLE AS HE STATED ISSUE WAS WITH SYRINGE AS ISSUE BEGAN WHEN NEEDLE WAS NOT ATTACHED TO SYRINGE HE EXPERIENCED RESISTANCE WHEN PULLING THE PLUNGER BACK AND THEN WHEN NEEDLE WAS ATTACHED ISSUE PERSISTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216711 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8244745 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other