BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ ASSEMBLY NAC Y-SITE TUBING

    MDR report key: 14962249 · Received July 8, 2022

    Report

    Report Number
    9616066-2022-00846
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 10, 2022
    Report Date
    July 28, 2022
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED BY THE CUSTOMER THAT THERE IS MIXED MATERIAL DETECTED IN THE BAGS WITH LARGER PORT DIAMETER. MIXED MATERIAL ISSUE IS DETECTED BAGS FOR THE 8100-027 (CUSTOMER P/N: 300-0000391-00) (B)(4) PCS FOUND WITH "LARGER" PORT DIAMETER AS PER THE PICTURE PROVIDED. TO IDENTIFY THE POTENTIAL ROOT CAUSE FOR THE FAILURE MODE REPORTED IN CONJUNCTION WITH THE MFT A GEMBA WALK WAS CARRIED OUT IN AUTOMATION AREA. DURING A GEMBA WALK IT WAS VISITED THE PACKAGING PROCESS IN PACKAGING AREA. PACKAGING OF MODEL REPORTED UNDER THIS COMPLAINT IS CARRIED OUT OVER A TABLE SHOWN IN IMAGE 9. ACCORDING TO THE INFORMATION PROVIDED BY PERSONNEL OF PACKAGING AREA, THEY TAKE THE MATERIAL FROM THE RACK AND EMPTY THE BAG INTO OTHER BAG, AND THEY WEIGHT THE BAG AND WHEN IT IS NEEDED IT NEEDS TO BE COMPLETED USING MATERIAL OF OTHER BAGS. HOWEVER, DURING THE GEMBA IT WAS NOTED THAT ON THE RACK OF MATERIAL, WERE BAGS WITH DIFFERENT MATERIALS AND LOT NUMBERS ALSO. MATERIAL ON THE RACK WAS REVIEWED AND THERE WAS FOUND BAGS WITHOUT IDENTIFICATION. THIS CAN BE CONSIDERED AS A POTENTIAL ROOT CAUSE SINCE SOME MATERIALS (FINISHES GOOD) LOOK VERY SIMILAR, AND IF THE MATERIAL IS NOT IDENTIFIED, IT COULD BE MIXED EASILY WHEN THE QUANTITY OF MATERIAL NEEDS TO BE COMPLETED WITH MATERIAL OF OTHER BAGS. ROOT CAUSE ANALYSIS AFTER INVESTIGATION, AND BY REVIEWING THE PROCESS, IT WAS DETERMINED AS THE MOST POSSIBLE ROOT CAUSE THAT COULD CONTRIBUTE TO THE MIXING OF MATERIAL IS: PERSONNEL FAILED IN THE HANDLE OF MATERIAL IN PACKAGING AREA BY PERSONNEL DURING THE PACKAGING PROCESS DUE TO NOT KEEP MATERIAL IDENTIFIED ADEQUATELY. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1500 BD ALARIS¿ ASSEMBLY NAC Y-SITE TUBING SETS WITH LARGER PORT DIAMETERS WERE INCORRECTLY MIXED INTO THE BAG OF PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MIXED MATERIAL ISSUE IS DETECTED BAGS FOR THE 8100-027 (CUSTOMER P/N (B)(6)) 1,500 PCS FOUND WITH "LARGER" PORT DIAMETER"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1500 BD ALARIS¿ ASSEMBLY NAC Y-SITE TUBING SETS WITH LARGER PORT DIAMETERS WERE INCORRECTLY MIXED INTO THE BAG OF PRODUCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MIXED MATERIAL ISSUE IS DETECTED BAGS FOR THE 8100-027 (CUSTOMER P/N 300-0000391-00 ) (B)(4) PCS FOUND WITH "LARGER" PORT DIAMETER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984392 BD ALARIS¿ ASSEMBLY NAC Y-SITE TUBING INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22044252

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown