BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 9717137 · Received February 17, 2020

    Report

    Report Number
    1911916-2020-00150
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 20, 2020
    Report Date
    February 17, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TEN SAMPLES WERE RECEIVED. THE SAMPLES CAME IN SEALED PACKAGING BLISTER. THEY HAVE THE PLASTIC SHIELD. THE LOT# PRINTED ON IS THE LOT# 9093554. THEY HAVE THE TOP AND BOTTOM WEBS FULLY SEALED MAKING DIFFICULT TO SEPARATE THEM AND OPEN THE PACKAGING BLISTER. THE BOTTOM WEB IS FORMED TO CREATE A KIND OF NEST AND THE PART IS PLACED IN THE "NEST". THEN THE TOP WEB IS PLACED, AND THE BLISTER IS SEALED. IN THIS CASE BOTH WEBS WERE FULLY SEALED AND NOT DETECTED DURING THE INSPECTIONS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE FILTER BLUNT FILL 18X1-1/2 PACKAGING CONTAMINATED A STERILE FIELD PRIOR TO USE. VERBATIM: ¿CUSTOMER REPORTS FOLLOWING: THE PACKAGE CANNOT BE OPENED IN A STERILE MANNER, DUE TO THE GLUING EXTENDING TO THE EDGE OF THE PACKAGE.¿ THE CLIENT STATES: ¿IN A STERILE MANNER.¿ THIS STATES STERILITY IN QUESTION AND THE COMPLAINT WILL CAUTIOUSLY BE REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE FILTER BLUNT FILL 18X1-1/2 PACKAGING CONTAMINATED A STERILE FIELD PRIOR TO USE. VERBATIM: ¿CUSTOMER REPORTS FOLLOWING: THE PACKAGE CANNOT BE OPENED IN A STERILE MANNER, DUE TO THE GLUING EXTENDING TO THE EDGE OF THE PACKAGE.¿ THE CLIENT STATES: ¿IN A STERILE MANNER.¿ THIS STATES STERILITY IN QUESTION AND THE COMPLAINT WILL CAUTIOUSLY BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181972 BD NEEDLE FILTER BLUNT FILL 18X1-1/2 BLUNT FILL NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 9093554 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other