BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 18GA 1-1/2IN SB TW

    MDR report key: 10705995 · Received October 20, 2020

    Report

    Report Number
    3002682307-2020-00317
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 25, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE SAMPLES, NO ISSUES WITH THE PRODUCT WERE OBSERVED. THE PRODUCT, MATERIAL REFERENCE NUMBER 304644 AND LOT NUMBER 0142368 IS SHOWN WITHIN THE PICTURES. THE INFORMATION LISTED ON THE INNER BAGS DOES NOT REFER TO THE FINAL PRODUCT, UNLIKE THE OUTER BOX. THE INFORMATION CAPTURED ON THE BAGS BELONGS TO THE INTERMEDIATE PROCESS; THE ASSEMBLY PROCESS OF THE NEEDLE. LOT NUMBER 0139224 IS THE ASSEMBLING LOT OF THE NEEDLES, WHICH IS A SUB-ASSEMBLY PRODUCT INVOLVED IN THE FINAL PRODUCT. THEREFORE, THESE NUMBERS WOULD DIFFER, WITH THE FINAL PRODUCT LOT NUMBER OF 0142368 AND THE SUB-ASSEMBLY LOT NUMBER OF 0139224. AS NO DEFECTS WERE IDENTIFIED FOR THIS INCIDENT, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. THE REPORTED ISSUE IS NOT RELATED TO A MANUFACTURING DEFECT, SO NO DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0142368 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE NS 18GA 1-1/2IN SB TW EXPERIENCED INCORRECT LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LABELING ON THE OUTER CARTON IS DIFFERENT FROM THAT ON THE BAG. THE ARTICLE DESCRIPTION AND THE LOT PAYMENTS ARE STILL PART OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE NS 18GA 1-1/2IN SB TW EXPERIENCED INCORRECT LABEL INFORMATION, WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LABELING ON THE OUTER CARTON IS DIFFERENT FROM THAT ON THE BAG. THE ARTICLE DESCRIPTION, AND THE LOT PAYMENTS ARE STILL PART OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173837 NEEDLE NS 18GA 1-1/2IN SB TW NEEDLE FMI BECTON DICKINSON, S.A. 0142368

    Patients

    Seq Age Sex Outcome Treatment
    1 Other