BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 9869453 · Received March 23, 2020

    Report

    Report Number
    9616656-2020-00254
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 3, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. (B)(6). INVESTIGATION SUMMARY: - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 8311942. INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS OR INNER SHIELDS ATTACHED. CONSUMER REPORTED AROUND 9 NEEDLES IN THE LOT ARE CLOGGED, PERFORMS THE FLOW TEST AND NOTHING COMES OUT. ALL 10 RETURNED PEN NEEDLES WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: - 9 WITH BENT NON-PATIENT END (NPE) CANNULA. - 1 WITH A BROKEN NPE CANNULA. 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 (AS REPORTED). SINCE ALL 10 PEN NEEDLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT AND 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 CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED 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, BROKEN NPE CANNULA). BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME INVESTIGATION CONCLUSION: 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, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AROUND 9 PN 32G 4MM 5B XTW EASYFLOW LA WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHE INFORMS THAT SHE USES INSULIN ON HER AUNT AND AROUND 9 NEEDLES IN THE LOT ARE CLOGGED, PERFORMS THE FLOW TEST AND NOTHING COMES OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334103 PN 32G 4MM 5B XTW EASYFLOW LA PEN NEEDLE FMI BECTON DICKINSON AND CO. 8311942

    Patients

    Seq Age Sex Outcome Treatment
    1 Other