BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SHORT PEN NEEDLE

    MDR report key: 15664450 · Received October 24, 2022

    Report

    Report Number
    9616656-2022-01135
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 27, 2022
    Report Date
    January 3, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201099
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 09-NOV-2022. CUSTOMER RETURNED ONE OPENED 31 GAUGE, 8MM PEN NEEDLE AND ONE UNOPENED 31 GAUGE, 8MM PEN NEEDLE FROM LOT 1251940. THE USED PEN NEEDLE¿S CANNULA WAS NEITHER BROKEN NOR BENT. WHEN TESTED ON A SKIN ANALOG, THE UNUSED PEN NEEDLE DID NOT BREAK OR BEND. NEITHER PEN NEEDLE FEATURED ANY KIND OF DAMAGE AFTER USE. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE NEEDLE BENDING DURING USE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ SHORT PEN NEEDLE EXPERIENCED THE CANNULA BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING 1 PEN NEEDLE THAT BROKE DURING INJECTION. WAS ABLE TO REMOVE ON HER OWN. HAD SOME BLEEDING. CALLER DENIED REUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ SHORT PEN NEEDLE EXPERIENCED THE CANNULA BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING 1 PEN NEEDLE THAT BROKE DURING INJECTION. WAS ABLE TO REMOVE ON HER OWN. HAD SOME BLEEDING. CALLER DENIED REUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377465 BD ULTRA-FINE¿ SHORT PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320109 1251940 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown