BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 8760988 · Received July 3, 2019

    Report

    Report Number
    9616656-2019-00592
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 5, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    MATERIAL NO: 320122, BATCH NO: 8150783. IT WAS REPORTED BY CONSUMER THAT DURING USE OF THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G NOTHING COMES OUT OF THE PEN NEEDLE WHEN HE PRESSES THE PLUNGER. IT DISPENSES COUPLE OF DROPS, BUT NOTHING COMES OUT LATER DURING THE INJECTION. THIS OCCURRED ON 10 SEPARATE OCCASIONS BUT THE DATE/TIME IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NOTHING COMES OUT OF THE PEN NEEDLE WHEN HE PRESSES THE PLUNGER. IT DISPENSES COUPLE OF DROPS, BUT NOTHING COMES OUT LATER DURING THE INJECTION. HE DOES NOT DO PRIMING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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. ROOT CAUSE DESCRIPTION : ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    MATERIAL NO: 320122, BATCH NO: 8150783. IT WAS REPORTED BY CONSUMER THAT DURING USE OF THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G NOTHING COMES OUT OF THE PEN NEEDLE WHEN HE PRESSES THE PLUNGER. IT DISPENSES COUPLE OF DROPS, BUT NOTHING COMES OUT LATER DURING THE INJECTION. THIS OCCURRED ON 10 SEPARATE OCCASIONS BUT THE DATE/TIME IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NOTHING COMES OUT OF THE PEN NEEDLE WHEN HE PRESSES THE PLUNGER. IT DISPENSES COUPLE OF DROPS, BUT NOTHING COMES OUT LATER DURING THE INJECTION. HE DOES NOT DO PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555220 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8150783 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other