BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 10532207 · Received September 14, 2020

    Report

    Report Number
    9616657-2020-00145
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 2, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR BENT NPE, BROKEN NPE, GLUCOSE LEVEL & DIFFICULT/UNABLE TO OPERATE ON LOT # 9283654. A REVIEW OF RISK MANAGEMENT DOCUMENT 149RMN-0004-01 REVISION 19, INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE, BENT NPE, BROKEN NPE, GLUCOSE LEVEL, DIFFICULT/UNABLE TO OPERATE)( WAS CAPTURED AND ADDRESSED 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 AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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: CUSTOMER RETURNED (1) OPEN 4MM, 32G PEN NEEDLE WITHOUT THE TEAR DROP LABEL OR INNER SHIELD. CUSTOMER STATES THAT PEN NEEDLE LOOKED BROKEN AND BENT AT NON PATIENT END, SUGAR WENT UP 70 POINTS AND CONSUMER BELIEVES HE DID NOT RECEIVED HIS DOSAGE. THE RETURNED PEN NEEDLE WAS EXAMINED AND NO BENT OR BROKEN NON PATIENT END OF THE CANNULA WAS OBSERVED. ALSO, THE SAMPLE WAS TESTED AND WAS ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: 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 THE CANNULA BROKE AND FULL DOSE OF INSULIN WAS NOT DELIVERED AND HYPERGLYCEMIA OCCURRED DURING USE WITH A BD ULTRA FINE¿ PEN NEEDLES. PATIENT ADMINISTERED ADDITIONAL DOSE OF INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT PEN NEEDLE LOOKED BROKEN AND BENT AT NON PATIENT END. SUGAR WENT UP 70 POINTS AND CONSUMER BELIEVES HE DID NOT RECEIVED HIS DOSAGE. CONSUMER GAVE HIMSELF A SECOND INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991693 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 320122 9283654 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other