BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G X 4MM BENELUX

    MDR report key: 9273228 · Received November 4, 2019

    Report

    Report Number
    9616656-2019-01067
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 18, 2019
    Report Date
    December 10, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 8352686, CAT. NO. 325103. VISUAL EXAMINATION OF THE RETURNED SAMPLES WAS CARRIED OUT AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON TWO SAMPLES. NO ISSUES WERE OBSERVED WITH THE PATIENT END OF 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CONCLUSION: AS THE SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PN 32G X 4MM BENELUX EXPERIENCED CANNULA BREAKING OFF OR PULLING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROBLEM: THE NEEDLE MAY SOMETIMES REMAIN PARTIALLY IN THE PEN WHEN USED (LOT 9092789). THIS HAS ALREADY HAPPENED A NUMBER OF TIMES, SO WE FIND IT NECESSARY TO MAKE A NOTIFICATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AN UNSPECIFIED NUMBER OF PN 32G X 4MM BENELUX EXPERIENCED CANNULA BREAKING OFF OR PULLING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROBLEM: THE NEEDLE MAY SOMETIMES REMAIN PARTIALLY IN THE PEN WHEN USED (LOT 9092789). THIS HAS ALREADY HAPPENED A NUMBER OF TIMES, SO WE FIND IT NECESSARY TO MAKE A NOTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065250 PN 32G X 4MM BENELUX PEN NEEDLE FMI BECTON DICKINSON AND CO. 9092789

    Patients

    Seq Age Sex Outcome Treatment
    1 Other