BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ PEN NEEDLE

    MDR report key: 9403516 · Received December 3, 2019

    Report

    Report Number
    2243072-2019-02700
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 15, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED FIVE (5) USED 32GX4MM BD PEN NEEDLES WITHOUT A COVER OR TEAR DROP LABEL ATTACHED. CUSTOMER REPORTED NEEDLE BLOCKED, NEEDLE(S) BENT, AND REAR CANNULA END IS BROKEN. ALL FIVE RETURNED PEN NEEDLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: TWO WITH A BENT NON-PATIENT END (NPE) CANNULA. TWO WITH A BROKEN NPE CANNULA. ONE WITH A STRAIGHT NPE CANNULA. THE SAMPLE WITH A STRAIGHT NPE CANNULA WAS TESTED FOR FLOW USING A TEST PEN INJECTOR, BUT THE PEN NEEDLE WAS NOT ABLE TO EXPEL PROPERLY. A WIRE TEST WAS THEN PERFORMED ON THIS SAMPLE: THE WIRE PASSED THROUGH THE CANNULA, HOWEVER, THERE WAS A SMALL, CLEAR RESIDUE OBSERVED AT THE TIP OF THE WIRE AFTER BEING THROUGH THE CANNULA. UNDER THE MICROSCOPE THE RESIDUE WAS IDENTIFIED AS RESIDUAL SILICONE FROM THE MANUFACTURING PROCESS. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE SAMPLES WITH A BENT OR BROKEN NPE CANNULA. SINCE THE FOUR PEN NEEDLES WITH BENT OR BROKEN NPE CANNULAS WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE FOR THE BENT OR BROKEN NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. UNABLE TO PERFORM A DHR REVIEW DUE TO AN UNKNOWN LOT NUMBER. THE POSSIBLE ROOT CAUSE FOR THIS ISSUE (CLOG): SOME RESIDUAL SILICONE FROM THE MANUFACTURING LUBRICATION PROCESS COULD BE THE CAUSE FOR SLIGHT BLOCKAGE OF THE FLOW. THE POSSIBLE ROOT CAUSE FOR THESE ISSUES (BENT NPE CANNULA, BROKEN NPE CANNULA) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ PEN NEEDLE WAS BLOCKED AND BENT, WITH THE NON-PATIENT END BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " NEEDLE BLOCKED, NEEDLE(S) BENT REAR CANNULA END IS BROKEN."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ PEN NEEDLE WAS BLOCKED AND BENT, WITH THE NON-PATIENT END BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " NEEDLE BLOCKED NEEDLE(S) BENT REAR CANNULA END IS BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201666 UNSPECIFIED BD¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other