BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 10848633 · Received November 16, 2020

    Report

    Report Number
    9616656-2020-01144
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 20, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 11/16/2020 H.6. INVESTIGATION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE BENT NPE ON LOT # 0091882. CUSTOMER RETURNED (20) 4MM, 32G PEN NEEDLES (10 OPEN WITHOUT THE TEAR DROP LABEL, 10 SEALED) WITH THE SHELF CARTON FROM LOT # 0091882. CUSTOMER STATES THAT THE NEEDLE IS BENT IN ITS INNER PART (NON PATIENT END). ALL RETURNED PEN NEEDLES WERE EXAMINED AND ONE EXHIBITED A BENT NON 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE IS USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PN 32G 4MM 5B XTW EASYFLOW LA WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ONE NEEDLE IS BENT IN ITS INNER PART (NON PATIENT END). CUSTOMER ALWAYS DOES THE FLOW TEST PRIOR THE APPLICATION, BUT REPORT IT COULD HAS BEEN ANOTHER MOTHER THAT WOULD THINK THE INSULIN WAS BEING APPLIED AND IT WASN'T. IN PHONE CONTACT MADE WITH CUSTOMER, SHE CONFIRMED THAT THE PRODUCT INFORMATION ARE THE SAME FROM RECORD 1901091. SHE FURTHER REPORTED PREVIOUS UNITS WITH CANNULA PATIENT END BENT, AND NEEDLES CLOGGED, WITHOUT EVENT DATES DEFINED NOR PRODUCT INFORMATION EITHER."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER PHONE#: (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0091882; MEDICAL DEVICE EXPIRATION DATE: 2025-03-31; DEVICE MANUFACTURE DATE: 2020-03-31. MEDICAL DEVICE LOT #: UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. 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 AN UNSPECIFIED NUMBER OF PN 32G 4MM 5B XTW EASYFLOW LA WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ONE NEEDLE IS BENT IN ITS INNER PART (NON PATIENT END). CUSTOMER ALWAYS DOES THE FLOW TEST PRIOR THE APPLICATION, BUT REPORT IT COULD HAS BEEN ANOTHER MOTHER THAT WOULD THINK THE INSULIN WAS BEING APPLIED AND IT WASN'T. IN PHONE CONTACT MADE WITH CUSTOMER, SHE CONFIRMED THAT THE PRODUCT INFORMATION ARE THE SAME FROM RECORD (B)(6). SHE FURTHER REPORTED PREVIOUS UNITS WITH CANNULA PATIENT END BENT, AND NEEDLES CLOGGED, WITHOUT EVENT DATES DEFINED NOR PRODUCT INFORMATION EITHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308802 PN 32G 4MM 5B XTW EASYFLOW LA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1