BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE

    MDR report key: 11902666 · Received May 28, 2021

    Report

    Report Number
    9616656-2021-00602
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    May 3, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (8) 4MM, 32G PEN NEEDLES (4 OPEN WITHOUT THE TEAR DROP LABEL, 4 SEALED) FROM LOT # 0203815. CUSTOMER STATES THAT IT WAS HARD TO PUSH THE PATIENT END THROUGH. ALL RETURNED PEN NEEDLES WERE TESTED OR POINT GEOMETRY, LUBE, AND CANNULA OD. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 32G: 0.0090¿-0.0095¿): DATA: SAMPLE 1, POINT:GOOD,OUTER DIAMETER (IN):0.0091 ,LUBE:GOOD DATA: SAMPLE 2, POINT:GOOD, OUTER DIAMETER (IN):0.0091, LUBE: GOOD DATA: SAMPLE 3, POINT: GOOD, OUTER DIAMETER (IN):0.0092, LUBE:GOOD. DATA: SAMPLE 4, POINT: GOOD, OUTER DIAMETER (IN):0.0092, LUBE:GOOD. DATA: SAMPLE 5, POINT: GOOD, OUTER DIAMETER (IN):0.0091, LUBE:GOOD. DATA: SAMPLE 6, POINT: GOOD, OUTER DIAMETER (IN):0.0091, LUBE:GOOD. DATA: SAMPLE 7, POINT:GOOD, OUTER DIAMETER (IN):0.0091, LUBE:GOOD. DATA: SAMPLE 8, POINT:GOOD, OUTER DIAMETER (IN):0.0091, LUBE:GOOD. ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE WAS DIFFICULT TO USE DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, SHE HAS A HARD TIME PENETRATING HER SKIN WHEN TAKING INJECTION. STATED, SHE DOES GET HER COMPLETE DOSAGE, ITS JUST HARD PUSHING THE PATIENT END THROUGH. STATED, DOES NOT RE-USE AND ROTATES INJECTION SITES."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 DIFFICULT TO USE DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, SHE HAS A HARD TIME PENETRATING HER SKIN WHEN TAKING INJECTION. STATED, SHE DOES GET HER COMPLETE DOSAGE, ITS JUST HARD PUSHING THE PATIENT END THROUGH. STATED, DOES NOT RE-USE AND ROTATES INJECTION SITES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799476 BD ULTRA-FINE PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0203815

    Patients

    Seq Age Sex Outcome Treatment
    1