BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLE

    MDR report key: 16566402 · Received March 17, 2023

    Report

    Report Number
    9616656-2023-00232
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 21, 2023
    Report Date
    June 15, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2060476, MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027, DEVICE MANUFACTURE DATE: 01-MAR-2022. MEDICAL DEVICE LOT #: 2040131, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027, DEVICE MANUFACTURE DATE: 09-FEB-2022. MEDICAL DEVICE LOT #: 1195507, MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026, DEVICE MANUFACTURE DATE: 14-JUL-2021.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 09-JUN-2023. H6: INVESTIGATION SUMMARY: THREE OPEN 32G X 4MM PEN NEEDLE SAMPLE WERE RETURNED FROM LOT. NO. 2040131, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON ALL THREE SAMPLES AND BENT NON PATIENT END OF CANNULA WAS OBSERVED ON TWO SAMPLES AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE REMAINING SAMPLE. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TEST COULD BE CARRIED OUT. TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 2060476, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE. A CLOG TEST AS PER (B)(4) WAS CARRIED OUT ON THE REMAINING SAMPLE AND NO ISSUES WERE OBSERVED. TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 1195507, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE SECOND SAMPLE. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TEST COULD BE CARRIED OUT. 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. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ PRO PEN NEEDLE WAS UNABLE TO DELIVER THE DRUG SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE PATIENT'S REPORT IS THAT THE DRUG SOLUTION DID NOT COME OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ PRO PEN NEEDLE WAS UNABLE TO DELIVER THE DRUG SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE PATIENT'S REPORT IS THAT THE DRUG SOLUTION DID NOT COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665930 BD MICRO-FINE¿ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown