BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ NEEDLE-FREE VALVE

    MDR report key: 17699357 · Received September 7, 2023

    Report

    Report Number
    9616066-2023-01857
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 21, 2023
    Report Date
    December 14, 2023
    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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. LOT NUMBERS IDENTIFIED DURING INVESTIGATION. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 22118573. D4. MEDICAL DEVICE EXPIRATION DATE: 11/04/2026. H4. DEVICE MANUFACTURE DATE: 2022-11-04. D4. MEDICAL DEVICE LOT #: 22118574. D4. MEDICAL DEVICE EXPIRATION DATE: 11/04/2026. H4. DEVICE MANUFACTURE DATE: 2022-11-04. INVESTIGATION RESULTS: ALTHOUGH A 5000R PRODUCT WAS RETURNED FOR INVESTIGATION, NO SAMPLES WERE RECEIVED FOR INVESTIGATION BY THE CUSTOMER ADVOCACY TEAM. NO LOT NUMBER WAS PROVIDED TO ASSIST THE INVESTIGATION, HOWEVER THE CUSTOMER REPORTED THAT THE LASER ID WERE FROM 223193A TO 223233B. THE CUSTOMER INDICATES THAT DURING INSPECTION OF THE COMPONENT, THE MALE LUERS OF 103 PRODUCTS WERE BREAKING DURING THE DETACH ASSESSMENT USING A 4.5IN-LB CALIBRATED TORQUE DRIVER. FURTHER INSPECTION BY THE CUSTOMER REPORTED THAT THE LOCATION OF THE BREAKAGE WAS THE LUER TIP WHICH WAS NOT IN CONTACT WITH ADHESIVE. AS PART OF THE INVESTIGATION, THE CUSTOMER PROVIDED PHOTOGRAPHS OF THE SITE OF BREAKAGE, WHICH CONFIRMED THAT THE MALE LUER TIP HAD BROKEN AWAY, WITH STRESS MARKS VISIBLE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE LASER ID FROM THE 5000R COMPONENT CONFIRMED A POSSIBLE LOT NUMBER TO BE EITHER 22118573 OR 22118574; THE PRODUCTION RECORDS FOR BOTH LOTS DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A FAILURE INVESTIGATION WAS CONDUCTED BY THE MANUFACTURING SITE IN ORDER TO IDENTIFY A POTENTIAL SOURCE FOR THE REPORTED DAMAGE; HOWEVER A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE IDENTIFIED IN THIS INSTANCE. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED THE PRODUCTION PERSONNEL HAS BEEN INFORMED OF THIS REPORT AND WILL CONTINUE TO MONITOR THE INCOMING FEEDBACK AND REMAIN VIGILANT TO ISSUES OF THIS NATURE DURING FUTURE PRODUCTION. ADDITIONALLY, THE MANUFACTURING SITE CONFIRMED THAT A NEW MOLD TOOL IS CURRENTLY BEING VALIDATED, WHICH WILL REPLACE THE TOOLING USED ON THESE COMPONENTS. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED FEEDBACK WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE 5000R PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 103 BD SMARTSITE¿ NEEDLE-FREE VALVES WERE FOUND TO HAVE MALE LUERS THAT WOULD EASILY BREAK DURING A DETACHMENT ASSESSMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SMARTSITE 5000R MANUFACTURED IN TIJUANA IS SENT TO BORLA IN ITALY WHERE THEY ATTACH IT TO OUR VIAL ACCESS DEVICE USING UV CURE ADHESIVE. DURING INSPECTION AFTER ASSEMBLY, IT WAS DISCOVERED THAT THE MALE LUER WAS BREAKING DURING DETACH ASSESSMENT USING A 4.5IN-LB CALIBRATED TORQUE DRIVER. THE DETORQUE TEST IS CONDUCTED TO ENSURE PROPER ADHESION OF THE SMARTSITE TO THE VIAL ACCESS DEVICE AND WASN¿T INTENDED TO CHECK THE INTEGRITY OF THE SMARTSITE MALE LUER. WE CONDUCTED 100% DETORQUE TESTING AT 4.5IN-LBS ON THE 7500PC LOT AND FOUND 103 SMARTSITES THAT BROKE AT THE MALE LUER. A CLOSE LOOK AT THE BREAK UNDER A MICROSCOPE SHOWED THAT THE AREA THAT BROKE WAS NOT IN CONTACT WITH THE ADHESIVE, SO I DO NOT BELIEVE THAT THE ADHESIVE WEAKENED THE ACRYLIC IN THE CLEAR BODY. THE LASER MARKS RANGE BETWEEN 223193A TO 223233B. I DID A CAVITY ANALYSIS, AND THESE WERE THE RESULTS. CAV ID: COUNT: CAV ID: COUNT: CAV ID: COUNT: CAV ID: COUNT: 1 4 13 1 25 2 37 0 2 0 14 5 26 1 38 2 3 4 15 11 27 5 39 0 4 1 16 7 28 2 40 3 5 0 17 1 29 11 41 0 6 5 18 0 30 8 42 0 7 4 19 1 31 0 43 0 8 0 20 5 32 2 44 0 9 6 21 0 33 0 45 0 10 5 22 1 34 0 46 0 11 0 23 3 35 0 47 0 12 0 24 3 36 0 48 0 THE CLUSTERS MAY INDICATE A WEAKNESS IN THE MOLD FLOW AT THE END OF FILL LOCATION, WHICH MAY CAUSE THE MALE LUER TO NOT BE AS ROBUST AS IT POSSIBLY COULD."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113618 BD SMARTSITE¿ NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22118574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown