BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 9721540 · Received February 18, 2020

    Report

    Report Number
    9616656-2020-00135
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 29, 2020
    Report Date
    February 25, 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
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED (68) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS OR INNER SHIELDS ATTACHED. CONSUMER REPORTED FINDING CLOGGED NEEDLES; CONSUMER ALSO REPORTED NON PATIENT END NEEDLE WAS BENT OVER. ALL 68 PEN NEEDLES WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: - 59 PEN NEEDLES WITH BENT NON-PATIENT END (NPE) CANNULAS - 5 PEN NEEDLES WITH BROKEN NPE CANNULAS - 4 PEN NEEDLES WITH STRAIGHT NPE CANNULAS; THESE 4 PEN NEEDLES WERE TESTED FOR FLOW USING A TEST PEN INJECTOR AND ALL 4 WERE ABLE TO EXPEL PROPERLY NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE RETURNED SAMPLES. THE BENT OR BROKEN NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED. SINCE ALL 68 PEN NEEDLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT OR BROKEN 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, BROKEN 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 THE BD ULTRA FINE¿ PEN NEEDLE WAS CLOGGED DURING USE AND THE CONSUMER COULDN'T COMPLETE THE FLOW CHECK. LOT#'S 9162654 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FINDING CLOGGED NEEDLES SINCE NOVEMBER. ABOUT 20 PEN NEEDLES PER BOX WILL NOT COMPLETE THE FLOW CHECK"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9162654. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-08-14. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT THE BD ULTRA FINE¿ PEN NEEDLE WAS CLOGGED DURING USE AND THE CONSUMER COULDN'T COMPLETE THE FLOW CHECK. LOT#'S 9162654 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FINDING CLOGGED NEEDLES SINCE NOVEMBER. ABOUT 20 PEN NEEDLES PER BOX WILL NOT COMPLETE THE FLOW CHECK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187636 BD ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2865 SEE SECTION H.10. 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other