BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 9821017 · Received March 11, 2020

    Report

    Report Number
    9616656-2020-00209
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    February 27, 2020
    Report Date
    March 3, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201198
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE CLOG OCCURRED WITH A BD ULTRA FINE¿ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER ENCOUNTERED NEEDLE BENDING DURING USE, HE PUSHES DOWN REALLY HARD ON THE PEN TRYING TO GET THE INSULIN TO FLOW, BECAUSE HE PUSHES REALLY HARD, HE SEES A LITTLE BLOOD ON THE INJECTION SITE. VERBATIM: CONSUMER REPORTED WHEN TAKING TRYING TO TAKE INJECTIONS, PATIENT END OF NEEDLE BENDS WHEN ASKED IF HE ROTATES INJECTION SITES, CONSUMER STATED, "YES" WHEN ASKED IF HE RE-USES PEN NEEDLES, CONSUMER STATED, "NO" STATED, HE PUSHES DOWN REALLY HARD ON THE PEN TRYING TO GET THE INSULIN TO FLOW STATED, BECAUSE HE PUSHES REALLY HARD, HE SEES A LITTLE BLOOD ON THE INJECTION SITE STATED, HE PRIMES MORE THAN TWO UNITS BEFORE TAKING INJECTION DID NOT SEEK MEDICAL CONSUMER IS REPORTING ONE BOX LOT: 9071856 CATALOG: 320119 DATE OF EVENT: 2020-02-27 STATED, 3 PEN NEEDLES AFFECTED SAME TWO ISSUES AS MENTIONED ABOVE, PATIENT END BENDS DURING INJECTION AND HE SEES BLOOD AFTER TRYING TO INJECT SAMPLES DISCARDED" THIS COMPLAINT CAPTURES THE EVENT THAT OCCURRED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285203 BD ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320119 9071856 00382903201198

    Patients

    Seq Age Sex Outcome Treatment
    1 Other