BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE

    MDR report key: 13120586 · Received December 30, 2021

    Report

    Report Number
    3002682307-2021-00672
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 3, 2021
    Report Date
    March 7, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306574 AND LOT NUMBER 1152011. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, DAMAGED SHELF CARTONS WERE OBSERVED. THERE WERE SEVERAL SAMPLES WHICH PRESENTED HOLES AND POOR PACKAGE INTEGRITY. THE CASE CARTONS SEEMED TO BE IN GOOD CONDITION. ALL LOTS PRODUCED ARE CHECKED PRIOR TO LOADING FOR PRODUCT INTEGRITY. THE PACKING LISTS WERE REVIEWED AND NO ISSUES WITH LOADING RECORDS WERE FOUND FOR THE LOT IN QUESTION. AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THE OBSERVED DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 56 BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE HAD MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BOX TEAR INSIDE CARTON."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 56 BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE HAD MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BOX TEAR INSIDE CARTON."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 56 BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE HAD MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BOX TEAR INSIDE CARTON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021111 BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE INTRAVASCULAR CATHETER NGT BECTON DICKINSON, S.A. 1152011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown