BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET TUR Y-TUBE

    MDR report key: 11584803 · Received March 29, 2021

    Report

    Report Number
    2243072-2021-00886
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 15, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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: 3/24/2021 H.6. INVESTIGATION: 2 SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. TENSILE STRENGTH TEST BY COMPLAINT SAMPLES: SBDM CONDUCT TENSILE STRENGTH TEST BY THE RECEIVED SAMPLES FROM CUSTOMER. 1) RUBBER TUBE TENSILE STRENGTH TEST OF RECEIVED COMPLAINT SAMPLES (SPEC.: 2.5KGF) 2) RUBBER TUBE TENSILE STRENGTH TEST OF RECEIVED COMPLAINT SAMPLES (SPEC.: 2.5KGF) SBDM CONDUCTED TENSILE STRENGTH TEST FOR RUBBER TUBE, BY RECEIVED SAMPLES, FOUND THAT THE TENSILE STRENGTH OF RECEIVED SAMPLES IS ALL IN OUR SPEC. (2.5KGF) HOUSE SAMPLE INSPECTION: SBDM INSPECTED LOT NO. 6010211, 6011061 & 6101041AS OF THE SAME LOT AND SIMILAR MANUFACTURING DATE LOT NUMBERS OF HOUSE SAMPLES, ALL COMPONENTS ARE IN SPEC ON THE HOUSE SAMPLES. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF SAME LOT NUMBER OF COMPLAINT SAMPLE (LOT NO. 6010211, 6011061 & 6101041), THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEW THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE WAS NO SIMILAR COMPLAINT IN THE SAME PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: SBDM RECEIVED COMPLAINT CASE WAS THAT THE YELLOW RUBBER EASILY FALLS OUT OF THE PATIENT PERITONEUM. SBDM CONDUCTED INSPECTION BY RECEIVED COMPLAINT SAMPLES FOR TENSILE STRENGTH TEST. ACCORDING TO THE TENSILE STRENGTH TEST FOR CIS CONNECTION POINT ALL SAMPLES ARE IN OUR SPEC. (2.5KGF). HOWEVER, THE LIKELY CAUSE THAT IT MIGHT BE NOT ENOUGH TO ENDURE STRENGTH WHEN THE TUR Y SET IS TWISTED ON ACTUAL CUSTOMER`S FIELD AND IT CAUSED THE COMPLAINT CASE. THEREFORE, SBDM CONDUCTED PREVENTIVE ACTION AND THE TENSILE STRENGTH WAS ENHANCED ABOUT 20% MORE COMPARE WITH PREVIOUS COMPLAINT TENSILE STRENGTH TEST RESULT. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 IV SET TUR Y-TUBES WERE LOOSE AND DISCONNECTED FROM THE "PATIENT PERITONEUM". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "YELLOW RUBBER EASILY FALLS OUT OF THE PATIENT PERITONEUM."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 IV SET TUR Y-TUBES WERE LOOSE AND DISCONNECTED FROM THE "PATIENT PERITONEUM". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "YELLOW RUBBER EASILY FALLS OUT OF THE PATIENT PERITONEUM"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480695 IV SET TUR Y-TUBE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1