BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE ¿ PEN NEEDLES

    MDR report key: 13535587 · Received February 15, 2022

    Report

    Report Number
    9616656-2022-00173
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    February 1, 2022
    Report Date
    April 19, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE# : (B)(6). INITIAL REPORTER ZIP CODE : (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE# : (B)(6). INITIAL REPORTER ZIP CODE : (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12-APR-2022. H.6. INVESTIGATION: FOUR OPEN 32G X 4MM PEN NEEDLE SAMPLES FROM LOT NO. 0253606, ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE FROM LOT NO.1152243, THREE OPEN 32G X 4MM PEN NEEDLE SAMPLE FROM LOT NO.0091912, SEVEN OPEN 32G X 4MM PEN NEEDLE SAMPLES FROM LOT NO. 0140220 AND THREE OPEN 32G X 4MM PEN NEEDLE SAMPLES FROM LOT NO. 0106051, CAT. NO. 320561 WERE RETURNED. VISUAL EXAMINATION WAS CARRIED OUT ON ALL RETURNED PEN NEEDLE SAMPLES AND IT WAS OBSERVED THAT THE CANNULA NON PATIENT END WAS BENT ON THREE PEN NEEDLE SAMPLES FROM LOT NO. 0253606, ONE PEN NEEDLE SAMPLE FROM LOT NO.1152243, THREE PEN NEEDLE SAMPLES FROM LOT NO.0091912, SEVEN PEN NEEDLE SAMPLES FROM LOT NO. 0140220 AND THREE PEN NEEDLE SAMPLES FROM LOT NO. 0106051. DUE TO THE CONDITION THE SAMPLES WERE RECEIVED NO CLOG TESTING COULD BE CARRIED OUT. A CLOG TEST WAS CARRIED OUT ON ONE SAMPLE FROM LOT. NO. 0253606 AS PER Q-SOP-183-DL AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL CONFIRMED SAMPLES WERE RETURNED OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 BD ULTRA-FINE ¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED TO THE PHARMACY THAT IN ONE PACKAGE AT LEAST 20 DEVICES WERE NOT PERMEABLE (DELIVERING).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 BD ULTRA-FINE ¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED TO THE PHARMACY THAT IN ONE PACKAGE AT LEAST 20 DEVICES WERE NOT PERMEABLE (DELIVERING).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 BD ULTRA-FINE ¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED TO THE PHARMACY THAT IN ONE PACKAGE AT LEAST 20 DEVICES WERE NOT PERMEABLE (DELIVERING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586020 BD ULTRA-FINE ¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0140220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown