BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE

    MDR report key: 8426804 · Received March 16, 2019

    Report

    Report Number
    9616656-2019-00250
    Event Type
    Injury
    Date Received
    March 16, 2019
    Date of Event
    February 28, 2019
    Report Date
    April 5, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903251056
    PMA / PMN Number
    K131358
    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: THIRTY THREE SEALED AND INTACT AND ONE OPEN 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 8122822, CAT. NO. 325105 ALONG WITH TWO OPENED 31G X 8MM PEN NEEDLE SAMPLES FROM AN UNKNOWN LOT. NO. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. VISUAL EXAMINATION WAS CARRIED OUT THE OPENED SAMPLE FROM LOT. NO. 8122822 AND A BENT PATIENT END OF CANNULA WAS OBSERVED, NO INDENTATION MARKS WERE OBSERVED ON THE SHIELD OR HUB. VISUAL EXAMINATION WAS CARRIED OUT ON THE THIRTY THREE SEALED SAMPLES FROM LOT. NO. 8122822 AND NO ISSUES WERE OBSERVED. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES FROM AN UNKNOWN LOT. NO. AND A BENT PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON THE SECOND SAMPLE. NO MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO TO THREE BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE WERE BROKEN DURING USE. THIS WAS HAPPENED IN TWO DIFFERENT PACK OF NEEDLES. PATIENT WENT TO SEE MEDICAL DOCTOR SINCE THERE WAS ONE CANNULA INSIDE PATIENT'S LEG, BUT THE PEN NEEDLE COULD NOT BE LOCATED. CUSTOMER¿S VERBATIM: ¿ THE CUSTOMER HAS BEEN USING THE PEN NEEDLES FOR A LONG TIME. IN THIS AND ANOTHER PACK, 3 OR 2 NEEDLES WERE OBSERVED TO BREAK THE NEEDLE. THE CUSTOMER HAS BROUGHT US THE PACK FOR COMPLAINT. ONE CANNULA IS STILL IN THE CUSTOMER LEG. ¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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 TWO TO THREE BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE WERE BROKEN DURING USE. THIS HAPPENED IN TWO DIFFERENT PACK OF NEEDLES. PATIENT WENT TO SEE MEDICAL DOCTOR SINCE THERE WAS ONE CANNULA INSIDE PATIENT'S LEG, BUT THE PEN NEEDLE COULD NOT BE LOCATED. CUSTOMER¿S VERBATIM: ¿THE CUSTOMER HAS BEEN USING THE PEN NEEDLES FOR A LONG TIME. IN THIS AND ANOTHER PACK, 3 OR 2 NEEDLES WERE OBSERVED TO BREAK THE NEEDLE. THE CUSTOMER HAS BROUGHT US THE PACK FOR COMPLAINT. ONE CANNULA IS STILL IN THE CUSTOMER LEG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219530 BD MICRO-FINE ULTRA¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8122822 00382903251056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other