BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMALE LL ADAPTOR

    MDR report key: 12135754 · Received July 8, 2021

    Report

    Report Number
    9616066-2021-51474
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 3, 2021
    Report Date
    July 7, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: NINE FEMALE LUER LOCK ADAPTORS, MODEL 1022-091-032, WAS RECEIVED BY THE CUSTOMER FOR INVESTIGATION. UPON VISUAL INSPECTION, 5 SAMPLES APPEARED THE SAME SIZE COMPONENT BELOW THE FINS (NON THREADED END OF LUER), 3 SAMPLES ANOTHER SIZE AND 1 SAMPLE A THIRD SIZE. THE ENDS OF THE FOUR LARGER LUERS WERE ALSO NOTED TO HAVE BEEN CUT AT AN ANGLE INSTEAD OF A STRAIGHT LINE. NO OTHER DEFECTS WERE OBSERVED. THE LUERS WERE INSPECTED UNDER MAGNIFICATION, AND COMPLETE OCCLUSION WITHIN THE ENTIRE LOWER HALF OF THE LUER (NON-THREADED END) WAS OBSERVED IN ALL RETURNED SAMPLES. THE COMPONENTS WERE MOLDED WITH A BROKEN CORE PIN AND THE BOND POCKET FILLED. THE CUSTOMER'S COMPLAINT THAT THE PART IS SHOWN WITH OCCLUSION WAS VERIFIED. DIMENSIONAL ANALYSIS OF THE ID/OD WAS PERFORMED. THE TUBING'S DIAMETER SPECIFICATIONS FOR 5 OF THE SAMPLES WERE 0.15", CONFIRMING FROM THE BILL OF MATERIALS THAT THE PART WAS WITHIN SPECIFICATION. THE OD OF 4 SAMPLES WERE 0.26", 0.260", 0.25" AND 0.20" WHICH DO NOT MATCH THE DIAMETER SPECIFICATIONS FROM THE BILL OF MATERIALS AS 0.150 VERIFYING THAT THE SAMPLES WERE NOT WITHIN SPECIFICATION. THE PRODUCT REPORTED WAS MANUFACTURED BY SUPPLIER (VYAIRE) AND MANUFACTURING INFORMATION WAS REQUESTED. THE SUPPLIER CONDUCTED A DHR REVIEW OF CATALOG 1022-091-032 LOT NO. 0004080700, MANUFACTURED ON 23SEP2019, AND IT WAS NOTICED THAT IT HAS A NCMR GENERATED FOR HUMIDITY TEST. RISK ANALYSIS WERE PERFORMED AND THE PRODUCT INVOLVED IN THE PERIOD OF TIME WERE SENT TO SCRAP. THE MATERIAL PROCESSED WERE INSPECTED AND APPROVED ACCORDING THE INTERNAL PROCESS. THE MOLD WAS TRANSFERRED FROM VYAIRE TO THE BD NORTH AMERICAN MOLDING CENTER (NAMC) IN DECEMBER 2019, DISASSEMBLED, INSPECTED AND CLEANED. THESE INSPECTIONS AND IF NECESSARY, CORRECTIONS ARE DONE TO ALL VYAIRE TRANSFER MOLD RECEIVED AT THE NAMC BEFORE THE MOLD RUNS. CURRENT PROCEDURE AT NAMC ARE DESIGNED TO PREVENT OCCURRENCES OF THIS TYPE. FOR ROOT CAUSE: CORE PIN BROKE-BOND POCKET, NAMC IN PROCESS CHECK WILL DETECT THE DEFECT. ONCE DETECTED, QUALITY PROCEDURES WOULD GUIDE THE CONTAINMENT AND SEGREGATION ACTIVITIES TO PREVENT THE DEFECT FROM REACHING THE CUSTOMER. FOR THIS CODE AND ALL CODES HAVING A BOND POCKET, OUR IN PROCESS INSPECTIONS ARE PERFORMED USING PIN GAGES TO CONFIRM THE BOND POCKET MEET REQUIREMENTS. THESE CHECKS ARE PERFORMED EACH SHIFT. IN THIS CASE OF THE COMPLAINT WHERE THE CORE PIN BROKE AND THE BOND POCKET IS COMPLETELY FILLED, THE PART WOULD FAIL THE GAGE CHECK. NO IMMEDIATE ACTION WAS REQUIRED SINCE THE MOLD WAS RELOCATED TO SITE BD NAMC, DISASSEMBLED, INSPECTED AND CLEANED, HOWEVER, A NOTIFICATION OF THE COMPLAINT WAS SUBMITTED TO BD NAMC ON 17JUN2021. INVESTIGATION CONCLUSION: THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: SINCE THE REPORTED MODEL IS SUPPLIER RELATED, MANUFACTURING INFORMATION WAS REQUESTED FROM THE SUPPLIER. MODEL 1022-091-032 WAS MANUFACTURED ACCORDING TO SUPPLIER INTERNAL PROCEDURE, HOWEVER, THE MOLD WAS TRANSFERRED FROM VYAIRE TO THE NORTH AMERICAN MOLDING CENTER (NAMC) ON DECEMBER 2019. IT WAS DISASSEMBLED, INSPECTED AND CLEANED AND NO ISSUES WERE FOUND DURING MANUFACTURING, THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FEMALE LL ADAPTOR WAS OCCLUDED. THIS OCCURRED ON 15 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE PART IS SHOWN WITH OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033657 FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 0004080700

    Patients

    Seq Age Sex Outcome Treatment
    1