BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8646360 · Received May 28, 2019

    Report

    Report Number
    9616656-2019-00480
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 10, 2019
    Report Date
    June 10, 2019
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 32G X 4MM BD PEN NEEDLE WITHOUT A TEAR DROP LABEL ATTACHED (USED). CONSUMER REPORTED NEEDLE BLOCKED. THE RETURNED SAMPLE WAS TESTED FOR FLOW USING A TEST PEN INJECTOR; THE RETURNED SAMPLE FAILED THE FLOW TEST. A WIRE TEST WAS THEN PERFORMED ON THE SAMPLE THAT FAILED THE FLOW TEST: IT PASSED. 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. 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. THE POSSIBLE ROOT CAUSE FOR THIS ISSUE: SOME RESIDUAL SILICONE FROM THE MANUFACTURING LUBRICATION PROCESS COULD BE THE CAUSE FOR BLOCKAGE OF THE FLOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY WERE UNABLE TO DELIVER MEDICATION WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 7101669. IT WAS REPORTED: NEEDLE BLOCKED.

    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: N/A. INITIAL REPORTER PHONE #: 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 THEY WERE UNABLE TO DELIVER MEDICATION WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122; BATCH NO: 7101669. IT WAS REPORTED: NEEDLE BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438077 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 7101669 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other