BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 13970585 · Received March 31, 2022

    Report

    Report Number
    9616656-2022-00361
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 14, 2022
    Report Date
    May 19, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVALUTION?:YES D.9. RETURNED TO MANUFACTURER ON: 05-MAY-2022 H.6. INVESTIGATION: TWENTY TWO SEALED 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 1082127, CAT. NO. 320524. A FUNCTIONALITY TEST AS PER Q-SOP-183-DL WAS CARRIED OUT ON ALL TWENTY TWO SAMPLES AND NO ISSUES WERE OBSERVED. 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. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ PEN NEEDLE EXPERIENCED A CASE OF THE OUTER COVER BEING UNABLE TO ATTACH, AND A CASE OF BEING DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER WANTED TO PUT THE NEEDLE BACK INTO THE PACKAGE AFTER USE AND THE PACKAGE WOULD NOT HOLD THE NEEDLES. HE HAS TO TURN THE NEEDLES DOWN DANGEROUSLY AND PULL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ PEN NEEDLE EXPERIENCED A CASE OF THE OUTER COVER BEING UNABLE TO ATTACH, AND A CASE OF BEING DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER WANTED TO PUT THE NEEDLE BACK INTO THE PACKAGE AFTER USE AND THE PACKAGE WOULD NOT HOLD THE NEEDLES. HE HAS TO TURN THE NEEDLES DOWN DANGEROUSLY AND PULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2900892 BD ULTRA-FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1082127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown