BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 31G 5MM 5B

    MDR report key: 11948039 · Received June 7, 2021

    Report

    Report Number
    9616656-2021-00632
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 24, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: 2021-06-21. H6: INVESTIGATION SUMMARY: ONE HUNDRED AND FIVE SEALED AND TWO OPEN 31G X 5MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 0287428, CAT. NO. 320522. VISUAL EXAMINATION OF THE TWO OPEN SAMPLES WAS CARRIED OUT AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TEST COULD BE CARRIED OUT. A CLOG TEST AS PER TP700483 WAS CARRIED OUT ON THIRTY SEALED SAMPLES 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS THE 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 1 BD PN 31G 5MM 5B WAS UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT THE NEEDLES WERE NOT PENETRABLE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ZIP CODE : UNKNOWN. A DEVICE EVALUATION IS PENDING 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 1 BD PN 31G 5MM 5B WAS UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT THE NEEDLES WERE NOT PENETRABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844846 PN 31G 5MM 5B HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0287428

    Patients

    Seq Age Sex Outcome Treatment
    1