BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ CATHETER

    MDR report key: 8878620 · Received August 9, 2019

    Report

    Report Number
    2243072-2019-01648
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 16, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DHR: A REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. NO PHYSICAL SAMPLES WERE NOT RECEIVED FOR TESTING AND EVALUATION; ONE PHOTO WAS PROVIDED FOR EVALUATION OF THIS INCIDENT. THE PHOTO DISPLAYED A NEXIVA 20GA UNIT WITH THE WINGED ADAPTER AND DUAL PORT ADAPTER WITH EXTENSION TUBING DISCONNECTED FROM THE WINGED ADAPTER AND A LOOSE Q-SYTE WITH BLUE CAP. BASED ON THE EVALUATION OF THE SUBMITTED PHOTO, THE DEFECT SEPARATION INSERTER FROM TUBING WAS CONFIRMED. THE PHOTO DISPLAYED THE EXTENSION TUBING SET SEPARATED FROM THE WINGED ADAPTER. CONCLUSION: ALTHOUGH THE UNIT WAS NOT RETURNED FOR EVALUATION, THE TREND WAS IDENTIFIED BY THE QDA FOR THIS DEFECT, IT IS LIKELY THAT THE FAILURE WAS DUE TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE EXTENSION TUBING/ ADAPTER JOINT. THIS DEFECT IS CREATED AT THE NEW ZONE 8 ADHESIVE DISPENSE STATION. WHEN THE ADHESIVE DISPENSE TIPS BECOME MISALIGNED, ADHESIVE IS NOT DISPENSED IN THE PROPER LOCATION LEADING TO AN INSUFFICIENT AMOUNT OF ADHESIVE IN THE TUBING/ADAPTER PORT JOINT. THIS FAILURE MODE OF THE PROCESS WAS INTRODUCED BY THE NEW STATION DESIGN, AND THE 100% ADHESIVE PRESENCE VISION SYSTEM WAS NOT CAPABLE OF DETECTING THESE FAILURES. THE MANUFACTURING DEPARTMENT IDENTIFIED THE ISSUE AND TOOK IMMEDIATE CORRECTIVE ACTION ON (B)(6) 2018 BY UPGRADING THE VISION SYSTEM ON BOTH PRODUCTION LINES TO BE ABLE TO DETECT ADHESIVE THAT WAS NOT IN THE CORRECT LOCATION. HOLDERS FOR THE ADHESIVE DISPENSE TIPS WERE ADDED TO THE MACHINE ON (B)(6) 2018 TO BETTER PROTECT THE TIPS FROM DAMAGE AND BECOMING MISALIGNED. CAPA (B)(4) HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE. MSAS FOR THE ADHESIVE VISUAL INSPECTION WERE CONDUCTED ON LINE 1 ON (B)(6) 2019, LINE 2 ON (B)(6)2019, AND LINE 3 ON (B)(6) 2019. WITHOUT THE LOT NUMBER IT IS IMPOSSIBLE TO SAY WHETHER THE LOT UNDER THIS INVESTIGATION WAS MANUFACTURED BEFORE OR AFTER THE COMPLETION OF THE CAPA ACTION ITEMS. BASED ON THE QDA, NO ADDITIONAL CORRECTIVE ACTION IS WARRANTED AT THIS POINT. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE UNSPECIFIED BD¿ CATHETER WHEN REMOVING THE CATHETER FROM THE PACKAGING, THE EXTENSION OF THE CATHETER WAS NOT CONNECTED MAKING IT INOPERABLE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: VERBALLY RECEIVED YESTERDAY THROUGH THE NURSE OF THE CATHETER TEAM OF THE HOSPITAL, THE QUALITY DEVIATION REPORT OF THE NEXIVA 20G CATHETER. THE SAME REPORTS THAT, WHEN REMOVING THE CATHETER FROM THE PACKAGING, THE EXTENSION OF THE CATHETER WAS RELEASED, MAKING IT IMPOSSIBLE TO USE

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE UNSPECIFIED BD¿ CATHETER WHEN REMOVING THE CATHETER FROM THE PACKAGING, THE EXTENSION OF THE CATHETER WAS NOT CONNECTED MAKING IT INOPERABLE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBALLY RECEIVED YESTERDAY THROUGH THE NURSE OF THE CATHETER TEAM OF THE HOSPITAL, THE QUALITY DEVIATION REPORT OF THE NEXIVA 20G CATHETER. THE SAME REPORTS THAT, WHEN REMOVING THE CATHETER FROM THE PACKAGING, THE EXTENSION OF THE CATHETER WAS RELEASED, MAKING IT IMPOSSIBLE TO USE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673394 UNSPECIFIED BD¿ CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other