BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMALE LL ADAPTOR

    MDR report key: 12422309 · Received September 3, 2021

    Report

    Report Number
    2243072-2021-02232
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 6, 2021
    Report Date
    September 15, 2021
    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 · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/15/2021. H.6. INVESTIGATION: TWO SAMPLES, MODEL 1023-092-071 LOT 0004063776, AND TWO PHOTOS WERE RECEIVED BY THE CUSTOMER FOR INVESTIGATION. UPON VISUAL INSPECTION, A BROKEN TIP WAS OBSERVED ON TWO SAMPLES RECEIVED FROM THE CUSTOMER. THE BREAK ON THE TIP IS NEAR THE BASE OF THE COMPONENT IT IS ATTACHED TO. NO OTHER DEFECTS WERE OBSERVED. THE CUSTOMER'S COMPLAINT THAT THE CONNECTOR WAS BROKEN WAS VERIFIED. THE PRODUCT REPORTED WAS MANUFACTURED BY SUPPLIER (VYAIRE) AND MANUFACTURING INFORMATION WAS REQUESTED. THE SUPPLIER CONDUCTED A DHR REVIEW, AND NO ISSUES WERE FOUND DURING THE MANUFACTURING OF THE REPORTED LOT. THE PRODUCT WAS MANUFACTURED ACCORDING TO INTERNAL PROCEDURE. WE ARE UNABLE TO PROVIDE ANY PROBABLE CAUSE OF THE BREAK AND CONNECTION POINT WITHIN THE DEVICE, SINCE THE EQUIPMENT AND FINAL PRODUCT WAS MANUFACTURED AT THE FORMER SUPPLIER (VYAIRE). THE MOLD WAS TRANSFERRED FROM VYAIRE TO THE NORTH AMERICAN MOLDING CENTER (NAMC) ON MAY 2020. IT WAS 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. SINCE THE MOLD WAS TRANSFERRED AND NO ISSUES WERE FOUND DURING MANUFACTURING, THE ROOT CAUSE COULD NOT BE DETERMINED. NAMC HAS PROCESS CONTROLS IN PLACE THAT WOULD DETECT SYSTEMIC DEFECTS LEADING TO THIS FAILURE MODE. THE INSPECTION AND CONTROL PROCESSES AT NAMC ARE DESIGNED DETECT, CONTAIN AND PREVENT RELEASE OF THIS AND ALL DEFINED DEFECTS. EVEN THOUGH THE SPECIFIC LOT WAS MANUFACTURED AT VYAIRE, THE SPECIFIC DEFECT (CRACK OR BROKEN) WAS NOT PRESENT IN THE OQ OR PQ QUALIFICATION RUNS FOR THE TOOL THAT IS USED TO MANUFACTURE THIS PART CODE AT NAMC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FEMALE LL ADAPTOR LUER-LOK COLLAR BROKE DURING USE AND LEAKED BLOOD. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE USE OF THE PRODUCT, THE PART WHERE A WARMING TUBE WAS CONNECTED BROKE, CAUSING BLOOD TO LEAK. NO PATIENT INJURY."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMALE LL ADAPTOR LUER-LOK COLLAR BROKE DURING USE AND LEAKED BLOOD. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE USE OF THE PRODUCT, THE PART WHERE A WARMING TUBE WAS CONNECTED BROKE, CAUSING BLOOD TO LEAK. NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317441 FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA 0004063776

    Patients

    Seq Age Sex Outcome Treatment
    1