BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE

    MDR report key: 12426299 · Received September 4, 2021

    Report

    Report Number
    9616656-2021-01099
    Event Type
    Malfunction
    Date Received
    September 4, 2021
    Date of Event
    August 10, 2021
    Report Date
    September 22, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 9/22/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (2) 4MM, 32G PEN NEEDLES (1 OPEN WITHOUT THE TEAR DROP LABEL, 1 SEALED) FROM LOT # 0231140. CUSTOMER STATES THAT INSULIN WILL NOT FLOW. BOTH RETURNED PEN NEEDLES WERE EXAMINED AND THE OPEN SAMPLE EXHIBITED A BENT NON PATIENT END OF THE CANNULA. THE SEALED SAMPLE WAS TESTED AND WAS ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. 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 RELATED. THE NON PATIENT END OF THE CANNULA WAS BENT DURING USE OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED SHE'S FINDING THE NON PATIENT END BENT AFTER ATTEMPTING TO INJECT HER INSULIN. STATED, NO INSULIN FLOW WHEN TAKING INJECTION, SHE REMOVES THE PEN NEEDLE, NON PATIENT END IS BENT. STATED, SHE DOES NOT PRIME BEFORE INJECTION. STATED, SHE'S NOT OVER TIGHTENING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED SHE'S FINDING THE NON PATIENT END BENT AFTER ATTEMPTING TO INJECT HER INSULIN. STATED, NO INSULIN FLOW WHEN TAKING INJECTION, SHE REMOVES THE PEN NEEDLE, NON PATIENT END IS BENT. STATED, SHE DOES NOT PRIME BEFORE INJECTION. STATED, SHE'S NOT OVER TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323651 BD ULTRA-FINE PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 0231140

    Patients

    Seq Age Sex Outcome Treatment
    1