BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G X 4MM BENELUX

    MDR report key: 11152949 · Received January 11, 2021

    Report

    Report Number
    9616656-2021-00010
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 15, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST RELATED COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PN 32G X 4MM BENELUX WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "I HAVE RECENTLY IN USE VIA DEABETISLIGA LOT NUMBER 0203705 SEE APPENDIX . OTHER DELIVERIES WERE GOOD THESE ARE OFTEN CLOGGED AND NOT USABLE AND BLUNT POINTS .I EXPECT AN ANSWER AND A COMPENSATION."

    Additional Manufacturer Narrative · 1

    "DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AN UNSPECIFIED NUMBER OF PN 32G X 4MM BENELUX WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "I HAVE RECENTLY IN USE VIA DEABETISLIGA LOT NUMBER 0203705 SEE APPENDIX . OTHER DELIVERIES WERE GOOD THESE ARE OFTEN CLOGGED AND NOT USABLE AND BLUNT POINTS .I EXPECT AN ANSWER AND A COMPENSATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42132 PN 32G X 4MM BENELUX HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0203705

    Patients

    Seq Age Sex Outcome Treatment
    1