BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9717611 · Received February 17, 2020

    Report

    Report Number
    9616657-2020-00025
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 27, 2020
    Report Date
    February 20, 2020
    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
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED (40) USED 32GX4MM BD PEN NEEDLES WITHOUT A COVER OR TEAR DROP LABEL ATTACHED. CONSUMER REPORTED PEN NEEDLES CLOGGED DURING INJECTION. ALL 40 PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT 38 EXHIBITED BENT NON-PATIENT END (NPE) CANNULA. THE TWO PEN NEEDLES THAT DID NOT EXHIBIT A BENT NPE CANNULA WERE TESTED FOR FLOW USING A TEST PEN INJECTOR: BOTH WERE ABLE TO EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE RETURNED SAMPLES. 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 40 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION 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. ROOT CAUSE DESCRIPTION THE POSSIBLE ROOT CAUSE FOR THIS ISSUE IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WERE CLOGGED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 9141946, IT WAS REPORTED THAT THE CUSTOMER ENCOUNTERED 30 PEN NEEDLES BEING CLOGGED DURING INJECTION FROM THREE BOXES INFORMED CONSUMER OF PROPER PLACEMENT OF NON PATIENT END AND TO COMPLETE THE FLOW CHECK WITH EACH PEN NEEDLE. CONSUMER WAS NOT DOING THIS PROCESS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WERE CLOGGED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 9141946. IT WAS REPORTED THAT THE CUSTOMER ENCOUNTERED 30 PEN NEEDLES BEING CLOGGED DURING INJECTION FROM THREE BOXES. INFORMED CONSUMER OF PROPER PLACEMENT OF NON PATIENT END AND TO COMPLETE THE FLOW CHECK WITH EACH PEN NEEDLE. CONSUMER WAS NOT DOING THIS PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181890 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 2865 9141946 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other