BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP 100 BOX 1200 US

    MDR report key: 11369751 · Received February 23, 2021

    Report

    Report Number
    9616656-2021-00179
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 29, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-18. INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL OR INNER SHIELD. CUSTOMER STATES THAT ONE PEN NEEDLE WAS CLOGGED DURING THE FLOW CHECK. ALL RETURNED PEN NEEDLES WERE TESTED AND ALL WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32G 4MM HP 100 BOX 1200 US WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ONE PEN NEEDLE WAS CLOGGED DURING THE FLOW CHECK. VERBATIM: CONSUMER REPORTED FOUND 1 PEN NEEDLE FROM THIS NEW BOX CLOGGED DURING FLOW CHECK. LOT #: 0203822CATALOG#: 320550DATE OF EVENT: 01/29/2021SAMPLES STATUS AWAITING SAMPLE".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 32G 4MM HP 100 BOX 1200 US WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ONE PEN NEEDLE WAS CLOGGED DURING THE FLOW CHECK. VERBATIM: CONSUMER REPORTED FOUND 1 PEN NEEDLE FROM THIS NEW BOX CLOGGED DURING FLOW CHECK. LOT #:0203822, CATALOG#: 320550. DATE OF EVENT: (B)(6) 2021 SAMPLES STATUS AWAITING SAMPLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266617 PEN NDL 32G 4MM HP 100 BOX 1200 US HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0203822 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1