BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLES

    MDR report key: 17243716 · Received June 30, 2023

    Report

    Report Number
    9616656-2023-00681
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 27, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 17-JUL-2023. H6: INVESTIGATION SUMMARY: THREE OPEN AND FORTY SEALED 31G X 5MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 2060470, CAT. NO. 320522. VISUAL EXAMINATION WAS CARRIED OUT ON THE THREE OPEN SAMPLES AND A BROKEN NON PATIENT END OF THE CANNULA WAS OBSERVED ON TWO SAMPLES AND A BENT NON PATIENT END OF THE CANNULA WAS OBSERVED ON ONE SAMPLE. DUE TO THE CONDITION OF THE RETURNED OPEN SAMPLES NO CLOG TESTING COULD BE CARRIED OUT. A CLOG TEST WAS CARRIED OUT ON 30 SEALED SAMPLES AND NO ISSUES WERE OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. ONE SEALED 31G X 5MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 0301643, CAT. NO. 320522. A CLOG TEST WAS CARRIED OUT ON THE RETURNED SAMPLE AND NO ISSUES WERE OBSERVED. ONE SEALED 31G X 5MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 0133295, CAT. NO. 320522. A CLOG TEST WAS CARRIED OUT ON THE RETURNED SAMPLE AND NO ISSUES WERE OBSERVED. AS ALL CONFIRMED SAMPLES WERE RETURNED OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD ULTRA-FINE¿ PEN NEEDLES INSULIN WAS UNABLE TO BE DELIVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT COMPLAINT AGAIN ABOUT PEN-NEEDLES. EVERY 4TH NEEDLES HAS NOT WORKED. THE NEEDLES DO NOT LET INSULIN THROUGH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD ULTRA-FINE¿ PEN NEEDLES INSULIN WAS UNABLE TO BE DELIVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT COMPLAINT AGAIN ABOUT PEN-NEEDLES. EVERY 4TH NEEDLES HAS NOT WORKED. THE NEEDLES DO NOT LET INSULIN THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485122 BD ULTRA-FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2060470

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown