BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G ETW X 7MM PEN NEEDLE

    MDR report key: 12393477 · Received August 31, 2021

    Report

    Report Number
    1920898-2021-00945
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    July 28, 2021
    Report Date
    October 1, 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: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 10/19/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (1) OPEN 7MM, 23G PEN NEEDLE WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT THE NEEDLE COULD NOT BE INJECTED PROPERLY. THE RETURNED PEN NEEDLE WAS TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD (SPECS: OUTER DIAMETER FOR 23G: 0.0260¿-0.0265¿). THE POINT EXHIBITED PROPER GEOMETRY, THE OUTER DIAMETER WAS MEASURED AS 0.0263¿, AND SUFFICIENT LUBE WAS OBSERVED. ALSO, NO BLOCKED/CLOGGED CANNULA WAS OBSERVED ON THE SAMPLE. ALL OBSERVATIONS FELL 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD 23G ETW X 7MM PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE COULD NOT BE INJECTED PROPERLY EVEN THOUGH IT WAS INJECTED BY THE HOSPITAL STAFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD 23G ETW X 7MM PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE NEEDLE COULD NOT BE INJECTED PROPERLY EVEN THOUGH IT WAS INJECTED BY THE HOSPITAL STAFF.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 1 BD 23G ETW X 7MM PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE COULD NOT BE INJECTED PROPERLY EVEN THOUGH IT WAS INJECTED BY THE HOSPITAL STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295600 23G ETW X 7MM PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 4736989 8275681 00382904736989

    Patients

    Seq Age Sex Outcome Treatment
    1