BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY NAC Y-SITE (0.104 POCKET) OEM

    MDR report key: 12186160 · Received July 17, 2021

    Report

    Report Number
    9616066-2021-51550
    Event Type
    Malfunction
    Date Received
    July 17, 2021
    Date of Event
    June 18, 2021
    Report Date
    September 17, 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: 8/23/2021. H.6. INVESTIGATION: THREE SAMPLES OF THE 8100-029 MODEL WITH THE LEAK FAILURE MODE WERE RECEIVED ON AUGUST 23RD, 2021, THE SAMPLES WERE INSPECTED AND DURING THE SAMPLE REVISION THE LEAK WAS CONFIRMED. SINCE IT WAS OBSERVED THAT THE LEAKAGE WAS BETWEEN THE BODY AND THE WHITE TOP, THE SAMPLES WERE SEPARATED TO CHECK WHAT COULD BE THE REASON OF THE LEAKAGE. WHEN THE SAMPLES WERE SEPARATED, IT WAS OBSERVED A DAMAGE IN THE TOP OF THE BODY. A REVISION OF THE PROCESS WAS CONDUCTED BY THE MFT, INVOLVING MOLDING AND MANUFACTURING TEAM, THE SAMPLES WERE REVIEWED TO A COMPONENT LEVEL AND NO QN¿S AND SIMILAR DEFECTS WERE FOUND DURING THE MANUFACTURING OF THE BODY COMPONENT TC10008269. A PROCESS REVISION WITH AUTOMATION TEAM WAS ALSO PERFORMED, NO QN¿S AND WORK ORDERS WERE FOUND DURING THE MANUFACTURING OF THE REPORTED LOTS, HOWEVER, DURING THE GEMBA WALK IT WAS MENTIONED THE ACCUMULATIONS IN THE LOADING RAILS OF THE MACHINE WAS THE POTENTIAL CAUSE OF THE DAMAGE IN THE BODY IN THE MACHINE RAILS WHEN THE LOTS OF THE 8100-029 WERE MANUFACTURED. ALSO, IT WAS MENTIONED BY THE TEAM THAT SOMETIMES THE PIECES COULD BE STUCK DURING THE LOADING PROCESS INTO THE MACHINE, HOWEVER, THE PERSONNEL IN CHARGE OF THE MACHINE DURING THE MANUFACTURING WAS USED A STEEL TOOL TO REMOVE THE STUCK MATERIAL, THE TOOL WAS CONSIDERED ALSO AS A POTENTIAL CONTRIBUTOR TO GENERATE THE DAMAGE IN THE BODY SINCE THE STEEL COULD DAME THE PARTS. A GRIPPER IN THE NACY -4 MACHINE WAS ALSO CONSIDERED AS A POTENTIAL CAUSE OF THE DAMAGE IN THE BODY, SINCE A POSSIBLE LOOSE GRIPPER COULD GENERATE A DAMAGE IN THE BODY DURING PROCESS. A REVISION OF THE PROCESS WAS CONDUCTED, AND THE DEFECT WAS DISREGARDED TO BE RELATED TO THE MOLDING TEAM SINCE NO TREND RELATED TO A DAMAGE BODY WAS FOUND, HOWEVER, DURING THE PROCESS REVISION IT WAS MENTIONED THE POSSIBLE DAMAGE IN THE BODY WAS RELATED TO ACCUMULATED MATERIAL IN THE RAILS DURING THE LOADING OF THE PARTS INTO THE PROCESS MACHINE, ALSO, IT WAS MENTIONED THAT THE PERSONNEL USED A TOOL WHICH IT WAS RELATED TO A DAMAGE AND IT WAS CONSIDERED AS A POTENTIAL CAUSE; ALSO A GRIPPER MACHINE WAS CONSIDERED AS POTENTIAL CAUSE OF DAMAGE, SINCE A LOOSE GRIPPER COULD DAMAGE THE BODY DURING THE LOADING PROCESS, THEREFORE, THE ROOT CAUSE OF THE DAMAGE IN THE BODY FAILURE COULD NOT BE CONFIRMED, HOWEVER, THE POTENTIAL CAUSES WERE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 ASSEMBLY NAC Y-SITE (0.104 POCKET) OEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE NOTICED THAT THE COMPONENT WAS LEAKING ON THE MIDDLE AREA, DURING THE EVALUATION ON SMITHS MEDICAL SITE IT WAS CONFIRMED THE ISSUE BY A QUALITY ENGINEER AND AFTER THE EVALUATION, WE NOTICE THAT THE MATERIAL HAS THE LEAKING ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. INITIAL REPORTER PHONE #: (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 20098542, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-09-04. MEDICAL DEVICE LOT #: 20098543, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-09-04. MEDICAL DEVICE LOT #: 20088991, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-08-14. MEDICAL DEVICE LOT #: 20088121, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2020-07-28. 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 4 ASSEMBLY NAC Y-SITE (0.104 POCKET) OEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE NOTICED THAT THE COMPONENT WAS LEAKING ON THE MIDDLE AREA, DURING THE EVALUATION ON SMITHS MEDICAL SITE IT WAS CONFIRMED THE ISSUE BY A QUALITY ENGINEER AND AFTER THE EVALUATION, WE NOTICE THAT THE MATERIAL HAS THE LEAKING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083060 ASSEMBLY NAC Y-SITE (0.104 POCKET) OEM INTRAVASCULAR ADMINISTRATION SET FPA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1