BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SALINE SYRINGE

    MDR report key: 8474996 · Received April 2, 2019

    Report

    Report Number
    1911916-2019-00341
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 25, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    K011982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: THREE PHOTOS WERE PROVIDED. THEY SHOW ONE SYRINGE WITH A SPLICE OF THE PACKAGING FLOW WRAP. ONE DEFECTIVE SAMPLE WAS CREATED AND PASSED THROUGH THE SENSOR OF THE PACKAGING FLOW WRAPPERS AND WAS REJECTED. FAILURE MODE IS VERIFIED. THIS LIKELY OCCURRED DURING THE PACKAGING FLOW WRAP PROCESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR THE LOT# 8201718 FOR THE SAME DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #8201718 DURING THIS PRODUCTION RUN. ROOT CAUSE DESCRIPTION: THIS LIKELY OCCURRED DURING THE PACKAGING FLOW WRAP PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD POSIFLUSH¿ SALINE SYRINGE HAD INCORRECT LABEL INFORMATION. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WRONG PACKAGE. PACKAGE OF POSIFLUSH SP IS NOT THE SAME AS BEFORE. IT SHOW THE PINK BATCH COLOR ON PACKAGE THAT NORMALLY CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265351 BD POSIFLUSH¿ SALINE SYRINGE SALINE FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8201718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other