BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD

    MDR report key: 17052217 · Received June 2, 2023

    Report

    Report Number
    9616066-2023-01069
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 15, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403237478
    PMA / PMN Number
    K051499
    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. H.3. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 07-JUN-2023. H6: INVESTIGATION SUMMARY TWO SAMPLES OF MATERIAL MX4436 WAS RETURNED FOR QUALITY INVESTIGATION. THE CUSTOMER COMPLAINT WAS VERIFIED BY VISUAL INSPECTION OF THE TUBING. INVESTIGATION OF THE SAMPLES SUBMITTED SHOW THAT ONE OF THE TUBING SAMPLES WAS CRACKED AT THE EXTENSION SET MANIFOLD PORT, AND THE OTHER SAMPLES WAS BROKEN AT THE LUER CONNECTOR. FURTHER INVESTIGATION OF THE BREAKS INDICATES THAT A LARGE AMOUNT OF FORCE WAS APPLIED AT THE CONNECTION LOCATION CREATING THE FAILURE. A DEVICE HISTORY RECORD REVIEW FOR MODEL MX4436 LOT NUMBER 23019085 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE ROOT CAUSE FOR THIS FAILURE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION CONDUCTED AT THE MANUFACTURING FACILITY. THE INVESTIGATION AT THE MANUFACTURING FACILITY DID NOT IDENTIFY ANY PART OF THE PRODUCTION PROCESS THAT WOULD HAVE APPLIED THE TYPE OF FORCE NEEDED TO BREAK THE TUBING AT THE LOCATIONS SEEN IN THE SAMPLES. ADDITIONALLY, THE CUSTOMER STATED THEY RECEIVED THE PRODUCT ALREADY BROKEN IN THE PACKAGE. THE POSSIBLE ROOT CAUSE FOR THE FAILURE IS THAT THE INFUSION SET WAS DAMAGED DURING TRANSPORTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD MAXGUARD¿ EXTENSION SETS WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD EACH FROM LOTS 22119025 AND 2319085 HAD ISSUES WITH BREAKAGE NEAR THE MANIFOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MX4436 IS BREAKING NEAR THE MANIFOLD THIS OCCURRED 2X W/ 2 DIFFERENT LOT #'S... 3. WAS THIS NOTED ON BEFORE USE OR DURING/AFTER USE? THIS WAS NOTED PRIOR TO USE 4. WAS THERE ANY PATIENT INVOLVEMENT? WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY? NO 5. WHAT PROCEDURE WAS BEING DONE DURING THE INCIDENT? TUBING WAS PULLED TO PREPARE PATIENT FOR SURGERY 6. WAS THERE ANY LEAKAGE FOUND? NO ITEM WAS DEFECTIVE IN PACKAGING 7. WHAT MEDICATION/SOLUTION WAS USED DURING THE INCIDENT? NONE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD MAXGUARD¿ EXTENSION SETS WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD EACH FROM LOTS 22119025 AND 2319085 HAD ISSUES WITH BREAKAGE NEAR THE MANIFOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MX4436 IS BREAKING NEAR THE MANIFOLD THIS OCCURRED 2X W/ 2 DIFFERENT LOT #'S. 3. WAS THIS NOTED ON BEFORE USE OR DURING/AFTER USE? THIS WAS NOTED PRIOR TO USE. 4. WAS THERE ANY PATIENT INVOLVEMENT? WAS THERE ANY ADVERSE EVENT OR SERIOUS INJURY? NO. 5. WHAT PROCEDURE WAS BEING DONE DURING THE INCIDENT? TUBING WAS PULLED TO PREPARE PATIENT FOR SURGERY 6. WAS THERE ANY LEAKAGE FOUND? NO ITEM WAS DEFECTIVE IN PACKAGING. 7. WHAT MEDICATION/SOLUTION WAS USED DURING THE INCIDENT? NONE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089924 BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE, STOPCOCK AND MANIFOLD INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22119025 10885403237478

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown