BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX AP

    MDR report key: 10031268 · Received May 6, 2020

    Report

    Report Number
    9616656-2020-00391
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Date of Event
    April 16, 2020
    Report Date
    April 17, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: TWO OPEN 32 G X 4 MM PRO PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9240218, CAT. NO. 320566. VISUAL EXAMINATION OF THE RETURNED SAMPLES WAS CARRIED OUT AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TESTING COULD BE CARRIED OUT. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE WITH THE SAMPLES PROVIDED. ROOT CAUSE DESCRIPTION: AS THE SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. RATIONALE: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 PEN NDL 32 G 4 MM PRO 100 BOX AP WERE FOUND BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD ULTRA-FINE PRO 4 MM PEN NEEDLES BLOCKAGE. ON AVERAGE 2 OR 3 PER BOX OF 100 ARE BLOCKED AND DO NOT WORK. THE CUSTOMER IS ON HIS FOURTH BOX OF BD ULTRA-FINES (IN DEFAULT OF NOVOFINES) AND THE PROBLEM CONTINUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495074 PEN NDL 32G 4MM PRO 100 BOX AP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9240218

    Patients

    Seq Age Sex Outcome Treatment
    1 Other