BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX8MM EU

    MDR report key: 8754112 · Received July 2, 2019

    Report

    Report Number
    9616656-2019-00585
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 7, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903296088
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE OPENED 30G X 8MM ASD SAMPLES WERE RETURNED FROM LOT. NO. 8170744, CAT NO. 329608. VISUAL EXAMINATION WAS CARRIED OUT AND A BENT NON PATIENT END OF THE CANNULA WAS OBSERVED ON TWO SAMPLES. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TESTING COULD BE CARRIED OUT. A CLOG TEST WAS CARRIED OUT ON THE THIRD SAMPLE 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Additional Manufacturer Narrative · 0

    THE CORRECTION IS AS FOLLOWS: D.2. COMMON DEVICE NAME: PEN NEEDLE H3 OTHER TEXT : SEE. H.10

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ARE THE CHANGES: D.4. MEDICAL DEVICE LOT #: 8170744. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. H.4. DEVICE MANUFACTURE DATE: 2018-06-19 H3 OTHER TEXT : SEE. H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAFETY SHIELD FAILURE OCCURRED DURING USE WITH A PEN NEEDLE AUTOSHIELD DUO 30GX8MM EU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLES ARE NOT ACTIVATING // SAFETY SHIELD WAS NOT ACTIVATED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAFETY SHIELD FAILURE OCCURRED DURING USE WITH A PEN NEEDLE AUTOSHIELD DUO 30GX8MM EU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLES ARE NOT ACTIVATING // SAFETY SHIELD WAS NOT ACTIVATED"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SAFETY SHIELD FAILURE OCCURRED DURING USE WITH A PEN NEEDLE AUTOSHIELD DUO 30GX8MM EU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLES ARE NOT ACTIVATING // SAFETY SHIELD WAS NOT ACTIVATED"

    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 SAFETY SHIELD FAILURE OCCURRED DURING USE WITH A PEN NEEDLE AUTOSHIELD DUO 30 G X 8 MM EU. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLES ARE NOT ACTIVATING // SAFETY SHIELD WAS NOT ACTIVATED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548747 PEN NEEDLE AUTOSHIELD DUO 30GX8MM EU PEN NEEDLE FMI BECTON DICKINSON AND CO. 8170744 00382903296088

    Patients

    Seq Age Sex Outcome Treatment
    1 Other