BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G ETW X 7MM PEN NEEDLE US

    MDR report key: 11115039 · Received January 4, 2021

    Report

    Report Number
    1920898-2020-01792
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    November 26, 2020
    Report Date
    January 12, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382904736989
    PMA / PMN Number
    K110105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: 2020-12-21. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) OPEN 7MM, 23G PEN NEEDLE WITHOUT ANY PACKAGING. CUSTOMER STATES THAT THE NEEDLE IS SHORT. THE RETURNED PEN NEEDLE WAS TESTED FOR PATIENT END CANNULA LENGTH (SPECS FOR 7MM CANNULA LENGTH: 0.229¿-0.323¿). THE PATIENT END OF THE CANNULA WAS MEASURED AS 0.275¿, WHICH FALLS WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8275681. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 23G ETW X 7MM PEN NEEDLE US NEEDLE WAS SHORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BDP: LOW FILL VOLUME-PEN DILUENT & OTHERS(SHORT NEEDLE).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 23G ETW X 7MM PEN NEEDLE US NEEDLE WAS SHORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BDP: LOW FILL VOLUME-PEN DILUENT & OTHERS (SHORT NEEDLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4292 23G ETW X 7MM PEN NEEDLE US PEN NEEDLE FMI BD MEDICAL - DIABETES CARE 4736989 8275681 00382904736989

    Patients

    Seq Age Sex Outcome Treatment
    1