BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ DUAL PORT WITH CAP 22GA 1.00IN (0.9 MM X 25 MM)

    MDR report key: 6993602 · Received November 1, 2017

    Report

    Report Number
    1710034-2017-00282
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    October 3, 2017
    Report Date
    October 10, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). INVESTIGATION: COMPLAINT: PACKAGE DAMAGED-DEFECTIVE-OTHER. VENT PLUG LOOSE-MISSING. DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHRS ARE AVAILABLE FOR REVIEW AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE. THIS COMPLAINT IS CLASSIFIED AS MDR. FINDINGS: A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON NEXIVA LINE 1 STARTING ON MAR 22, 2017 THROUGH MAR 23, 2017. ALL CHALLENGES WERE SUCCESSFUL AND NO QUALITY RELATED FINDINGS WERE DISCOVERED. SET-UP AND IN PROCESS SAMPLES INCLUDING (BUT NOT LIMITED TO) PACKAGE WATER/LEAK TEST AND DAMAGED-IMPROPERLY FORMED TRAYS AS WELL AS MISSING VENT PLUG (VISION-CHALLENGE) PASSED PER SPECIFICATION. INVESTIGATION CONCLUSION: RECEIVED 11 UNUSED UNITS INSIDE SEALED PACKAGES FROM LOT NUMBER 7080941. TWO (2) OF THE 11 RECEIVED PACKAGES WERE NOT WELL FORMED AND APPEARED TO BE ¿MELTED¿. THE SEAL WAS COMPROMISED AND IT HAD BEEN ¿BURST¿. THREE (3) OF THE 11 OBSERVED THE VENT PLUGS WERE PRESENT INSIDE THE PACKAGES BUT NOT ATTACHED TO THE DUAL ADAPTERS. PACKAGE INTEGRITY - THE DEFECT WAS CONFIRMED THROUGH THE INVESTIGATION. THE CLEAR PLASTIC POCKET SHRUNK BACK AND CAUSED A GAP IN THE SEAL. VENT PLUG - THE DEFECT WAS CONFIRMED THROUGH THE INVESTIGATION. THE VENT PLUGS WERE LOOSE IN THE PACKAGE. ROOT CAUSE DESCRIPTION: PACKAGE INTEGRITY - THE CAUSE OF THE DEFECT WAS THE SHRINK BACK OF THE PACKAGE. WHY THE PACKAGE SHRUNK BACK ON THESE TWO PACKAGES AND NOT THE OTHER UNITS PROVIDED WAS NOT DETERMINED. VENT PLUG - THE CAUSE OF THE VENT PLUG FALLING OUT IS THE RELAXATION OF THE MATERIAL DURING STERILIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING ON A BD NEXIVA¿ DUAL PORT WITH CAP 22GA 1.00IN (0.9 MM X 25 MM) WAS WARPED AND THE SEAL WAS NOT INTACT. REPORT OF PRODUCT MISSING VENT PLUG FROM Y-CONNECTION. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774300 BD NEXIVA¿ DUAL PORT WITH CAP 22GA 1.00IN (0.9 MM X 25 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7080941

    Patients

    Seq Age Sex Outcome Treatment
    1 Other