BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10891892 · Received November 24, 2020

    Report

    Report Number
    3002682307-2020-00356
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 29, 2020
    Report Date
    November 2, 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 · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). 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 0251117, IS SHOWN WITHIN THE PICTURES. SINCE NO DEFECT IS PRESENTED, IT HAS BEEN CONSIDERED NOT NECESSARY TO PERFORM THE DHR REVIEW. INVESTIGATION CONCLUSION: AFTER REVISION OF THE PICTURE PROVIDED, WE WOULD LIKE TO INFORM YOU THAT ANY NONCONFORMANCE HAS BEEN OBSERVED. COSTUMER ORDERED THE REFERENCE (B)(4); LOT 0251117, AND THIS IS WHAT WE PROVIDED. THE INFORMATION IN THE BAG, DOES NOT MAKE REFERENCE TO THE FINAL PRODUCT (AS THE BOX DOES), CONSIDERING THE INFORMATION FROM THE BAG BELONGS TO AN INTERMEDIATE PROCESS, (ASSEMBLING PROCESS OF THE NEEDLE). LOT 0245325 IS THE ASSEMBLING LOT OF THE NEEDLES, WHICH IS ALWAYS DIFFERENT TO THE FINAL LOT. ROOT CAUSE DESCRIPTION: 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 0245325 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 0251117 AND THE SUB-ASSEMBLY LOT NUMBER OF 0245325. RATIONALE: AS NO DEFECTS WERE IDENTIFIED FOR THIS INCIDENT, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE NS 18GA 1-1/2IN SB TW HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON THE DELIVERY NOTE AND ON THE OUTSIDE LABEL OF THE CARTON THE SAME BATCH NUMBERS ARE SHOWN. 0251117. HOWEVER, THE INNER BAG SHOWS THE BATCH NUMBER 0245325. THEREFORE, WE HAVE TO BLOCK THE GOODS, BECAUSE A CLEAR TRACEABILITY FOR SFM IS NOT GUARANTEED IN THIS WAY. THE QUICKEST SOLUTION IS THAT WE IMMEDIATELY RECEIVE A CONFIRMATION FROM BD WHICH GOODS ARE IN THE BOX. WHETHER THE NUMBER 0245325 IS CORRECT OR THE NUMBER 0251117.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354708 NEEDLE NS 18GA 1-1/2IN SB TW NEEDLE FMI BECTON DICKINSON, S.A. 0251117

    Patients

    Seq Age Sex Outcome Treatment
    1