BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32G 4MM

    MDR report key: 11386430 · Received February 26, 2021

    Report

    Report Number
    9616656-2021-00201
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 2, 2021
    Report Date
    April 13, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K933545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (6) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT THE NEEDLE CLOGS DURING INJECTION. ALL RETURNED PEN NEEDLES WERE EXAMINED AND ALL RETURNED SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM PROPERLY FLOWING THROUGH THE CANNULA. CUSTOMER STATES THAT THE NON PATIENT END IS BENT. ALL RETURNED PEN NEEDLES WERE EXAMINED AND ALL RETURNED SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM PROPERLY FLOWING THROUGH THE CANNULA.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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A PEN NEEDLE 32G 4MM THE NON PATIENT END BENT AND NEEDLE CLOGGED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER REPORTED NEEDLES BENT AT NON PATIENT END. NEEDLE CLOG DURING INJECTION. CONSUMER DOES NOT RE-USE. LOT #: 0092500. CATALOG #: 320122. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

    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 WHILE USING A PEN NEEDLE 32G 4MM THE NON PATIENT END BENT AND NEEDLE CLOGGED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER REPORTED NEEDLES BENT AT NON PATIENT END. NEEDLE CLOG DURING INJECTION. CONSUMER DOES NOT RE-USE. LOT #: 0092500, CATALOG #: 320122. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281636 PEN NEEDLE 32G 4MM PEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 0092500 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1