BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM

    MDR report key: 11457756 · Received March 10, 2021

    Report

    Report Number
    9616656-2021-00237
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 11, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FRN
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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: 2021-03-18. INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT THE NEEDLE CLOGGED DURING INJECTION. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 2 OUT OF 5 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM FLOWING THROUGH THE PEN NEEDLE PROPERLY. ALL REMAINING SAMPLES 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. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT NON PATIENT END OF THE CANNULA). ROOT CAUSE IS USER RELATED. THE NON PATIENT END OF THE CANNULA WAS BENT DURING USE OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320883 ,BATCH NO. 9121980, CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. CONSUMER DOES NOT RE-USE. DATE OF EVENT: (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320883, BATCH NO. 9121980. CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. CONSUMER DOES NOT RE-USE. DATE OF EVENT: (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351817 PEN NDL 32G 4MM HYPODERMIC SINGLE LUMEN NEEDLE FRN BECTON DICKINSON AND CO. 9121980

    Patients

    Seq Age Sex Outcome Treatment
    1