BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32GA 4MM 14BAG 700CASE JP

    MDR report key: 11298540 · Received February 8, 2021

    Report

    Report Number
    9616656-2021-00133
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 19, 2021
    Report Date
    March 12, 2021
    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

    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: 2/5/2021. H.6. INVESTIGATION: FIVE OPEN AND SEVEN SEALED 32G X 4MM PEN NEEDLE SAMPLES AND SEVEN PHOTS WERE RETURNED FROM LOT. NO. 0127742, CAT. NO.320136. VISUAL EXAMINATION WAS CARRIED OUT ON FIVE OPEN SAMPLES AND SEVEN PHOTOGRAPHS AND SEVEN SEALED SAMPLES AND EXCESSIVE LUBRICANT WAS OBSERVED ON THE NON PATIENT END OF ALL RETURNED SAMPLES. 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. THE ROOT CAUSE OF THIS ISSUE IS ADHESIVE SPLATTER FROM THE DISPENSE SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 PEN NDL 32GA 4MM 14BAG 700CASE JP HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED AS FOLLOWS: WHEN REMOVING THE TEAR DROP LABEL, A DIRT WAS FOUND ON THE PRODUCT.".

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 127742, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-05-06. MEDICAL DEVICE LOT #: 140204, MEDICAL DEVICE EXPIRATION DATE: 2025-05-31, DEVICE MANUFACTURE DATE: 2020-05-19. 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 3 PEN NDL 32GA 4MM 14BAG 700 CASE JP HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED AS FOLLOWS: WHEN REMOVING THE TEAR DROP LABEL, A DIRT WAS FOUND ON THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188699 PEN NDL 32GA 4MM 14BAG 700CASE JP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1