BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD DUO PEN NEEDLE 30GA 5MM

    MDR report key: 10653523 · Received October 8, 2020

    Report

    Report Number
    9616656-2020-01016
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 17, 2020
    Report Date
    September 28, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K110007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S2; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD. RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 9231934. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SAFETY PEN NEEDLE AUTO SHIELD DUO PEN NEEDLE, NEEDLE CLOG) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: CUSTOMER RETURNED (18) USED BD AUTOSHIELD DUO PEN NEEDLES FROM LOT 9231934. CUSTOMER REPORTED THAT NO INSULIN FLOWS WHEN TAKING THE INJECTION AND SOMETIMES DURING PRIMING. ALL 18 RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT 3 PEN NEEDLES EXHIBITED SUCCESSFUL ACTIVATION OF BOTH THE PATIENT END (PE) AND NON-PATIENT END (NPE) SAFETY MECHANISMS. 15 PEN NEEDLES EXHIBITED BENT NPE CANNULAS. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE BENT NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED (AS REPORTED). SINCE ALL 18 PEN NEEDLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. 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: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT NPE CANNULA) 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD HYPODERMIC SINGLE LUMEN NEEDLE WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NO INSULIN FLOWS WHEN TAKING THE INJECTION AND SOMETIMES DURING PRIMING. VERBATIM: PLEASE SEE RELATED FILE: (B)(4). FROM PHONE CALL ON (B)(6) 2020 15:58:18: CONSUMER STATED, NO INSULIN FLOW WHEN TAKING INJECTION AND SOMETIMES, PRIMING. STATED, HE SENT BACK SAMPLES WITH LETTER HE MAILED IN. 18 PEN NEEDLES AFFECTED. WENT OVER INSTRUCTION ON HOW TO PRIME AND INJECT. (B)(4) EMAIL RECEIVED¿(B)(6) 2020 09:46:16 LETTER RECEIVED IN (B)(4) AND SCANNED IN. CONSUMER IS WRITING REGARDING SAFETY PEN NEEDLES. HARD TO MAKE OUT HAND WRITING CONSUMER MENTIONED, RETURNING 18 PEN NEEDLES AND REQUESTING CREDIT?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118476 BD AUTOSHIELD DUO PEN NEEDLE 30GA 5MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 329515 9231934 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other