BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32GA 4MM 14BAG 700CASE JP

    MDR report key: 11168463 · Received January 13, 2021

    Report

    Report Number
    9616656-2021-00025
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 21, 2020
    Report Date
    March 5, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-01-15. H6: INVESTIGATION SUMMARY: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE, ONE OPEN POLYBAG AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 0070059, CAT. NO. 320136. A CLOG TEST WAS CARRIED OUT ON THE RETURNED SAMPLE AS PER (B)(4) 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 SAMPLE THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32GA 4MM 14BAG 700CASE JP WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED THAT DRUG DIDN'T COME OUT."

    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 32GA 4MM 14BAG 700CASE JP WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED THAT DRUG DIDN'T COME OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55150 PEN NDL 32GA 4MM 14BAG 700CASE JP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0070059

    Patients

    Seq Age Sex Outcome Treatment
    1