BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDLE¿ ULTRA-FINE III

    MDR report key: 8760408 · Received July 3, 2019

    Report

    Report Number
    9616656-2019-00591
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 15, 2019
    Report Date
    August 5, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    NSC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) OPEN 8MM, 31G PEN NEEDLE WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT INSULIN LEAKED OUT AND THE NEEDLE WAS BLUNT. THE RETUNED PEN NEEDLE WAS TESTED AND WAS ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED LEAKAGE. THE SAMPLE WAS ALSO EXAMINED UNDER THE MICROSCOPE AND EXHIBITED A HOOKED CANNULA POINT. 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. - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HOOKED POINT) - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (LEAKAGE) DAMAGED DURING USE OR DURING SHIELDING AFTER USE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEN NEEDLE¿ ULTRA-FINE III LEAKED INSULIN. THIS OCCURRED ON 3 OCCASIONS DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320108 BATCH NO: 8143539 IT WAS REPORTED THAT THE CONSUMER ENCOUNTERED INSULIN LEAK AND THAT THE NEEDLE WAS BLUNT. VERBATIM: CONSUMER REPORTED WHEN SHE TRIED INJECTING THE INSULIN, INSULIN LEAKED OUT. WHEN SHE LOOKED AT THE ONE NEEDLE WITH MAGNIFYING GLASS, SHE THINKS SHE NOTICED THE NEEDLE WAS BLUNT COMPARING WITH OTHER PEN NEEDLE. OCCURENCE-3, INCIDENT DATE- 6-15-2019. SAMPLE AVAILABLE. SHE USES THE NEW PEN NEEDLE EACH TIME OF HER INJECTION. SHE VISUALLY TESTS THE NEEDLE TO SEE IF ITS STRAIGHT. READ PRIVACY STATEMENT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PEN NEEDLE¿ ULTRA-FINE III LEAKED INSULIN. THIS OCCURRED ON 3 OCCASIONS DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320108, BATCH NO: 8143539. IT WAS REPORTED THAT THE CONSUMER ENCOUNTERED INSULIN LEAK AND THAT THE NEEDLE WAS BLUNT. VERBATIM: CONSUMER REPORTED WHEN SHE TRIED INJECTING THE INSULIN, INSULIN LEAKED OUT. WHEN SHE LOOKED AT THE ONE NEEDLE WITH MAGNIFYING GLASS, SHE THINKS SHE NOTICED THE NEEDLE WAS BLUNT COMPARING WITH OTHER PEN NEEDLE. OCCURENCE-3, INCIDENT DATE (B)(6) 2019. SAMPLE AVAILABLE. SHE USES THE NEW PEN NEEDLE EACH TIME OF HER INJECTION. SHE VISUALLY TESTS THE NEEDLE TO SEE IF ITS STRAIGHT. READ PRIVACY STATEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555178 BD PEN NEEDLE¿ ULTRA-FINE III INSULIN PEN NEEDLE NSC BECTON DICKINSON AND CO. 8143539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other