BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEXIUM CLOSED MALE LUER WITH FEMAILE CAP

    MDR report key: 10743611 · Received October 27, 2020

    Report

    Report Number
    2016493-2020-80003
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    October 1, 2020
    Report Date
    February 3, 2021
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    UDI-DI
    50885403221703
    PMA / PMN Number
    K053049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ALL REPORTS, INITIAL AND SUPPLEMENTALS, FOR MFR REPORT # 2016493-2020-80003 NEED TO BE CANCELLED AS THE NEW REPORT 9616066-2021-50178 HAS BEEN SUBMITTED. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: MFR REPORT #: THE ORIGINAL MFR REPORT # WAS 2016493-2020-80003 WAS SUBMITTED WITH THE INCORRECT MFR REGISTRATION SITE NUMBER. ALTHOUGH THE ORIGINAL MDR REFERENCED THE INCORRECT MFR SITE THE MDR WAS SUBMITTED (B)(6)2020 AND WAS ON TIME. THE NEW MDR MFR REPORT # IS 9616066-2021-50178.

    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: 10/7/2020 H.6. INVESTIGATION: THE CUSTOMER SENT IN A TEXIUM CONNECTOR ATTACHED TO A HALYARD HOMESERIES C-PUMP WITH THE COMPLAINT OF LEAKAGE AT THE TEXIUM SITE. AFTER TESTING, THE LEAKAGE COULD NOT BE DUPLICATED AND IS LIKELY DUE TO AN INCOMPATIBLE CONNECTION WITH BD DEVICE. THOUGH TEXIUM MEETS ISO SPECIFICATIONS, IT IS ADVISED THAT THE PRODUCT BE USED WITH SMARTSITE BD PRODUCTS. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10012241-0500 LOT NUMBER 17126211 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A ROOT CAUSE WAS NOT DETERMINED AS THE COMPLAINT OF LEAKAGE COULD NOT BE REPLICATED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 TEXIUM CLOSED MALE LUER WITH FEMALE CAP LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS A LEAKING ISSUE WHEN USING THE TEXIUM CLOSED MALE LUER WITH THE C-SERIES PUMP IV LINE. DESCRIBE CUSTOMER CONCERN THIS EVENT HAS OCCURED 7 TIMES IN THE LAST TWO DAYS AND SEVERAL TIMES EARLIER THIS WEEK-LAST PIR SUBMITTED. THE ISSUE IS WITH OUR TEXIUM, CT # 10012241-0500. OUR TEXIUM (FEMALE END) IS BEING CONNECTED TO THE CUSTOMER'S HALYARD C-SERIES ELASTOMERIC PUMP.....FIXED MALE SWIVEL LUER LOCK END OF THE IV LINE.... 5FU IS BEING ADMINISTERED AND HAS LEAKED BETWEEN THE CONNECTIONS. OUR TEXIUM IS BEING USED WITH ALL TYPES OF HOMECARE SETS AND APPLICATIONS, IE: BUDDY PUMP SET.....BUT THIS ISSUE OF LEAKING IS ONLY OCCURRING WITH THE C-SERIES PUMP-IV LINE.. PLEASE SEE THE ATTACHED PICTURES AS WELL. DESCRIBE PATIENT / HCP / USER IMPACT ONE OF THE PATIENTS WENT TO THE ER, THINKING THAT DUE TO THE LEAK THEY WERE NOT GETTING THEIR MEDICATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 TEXIUM CLOSED MALE LUER WITH FEMAILE CAP LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS A LEAKING ISSUE WHEN USING THE TEXIUM CLOSED MALE LUER WITH THE C-CERIES PUMP IV LINE. DESCRIBE CUSTOMER CONCERN THIS EVENT HAS OCCURED 7 TIMES IN THE LAST TWO DAYS AND SEVERAL TIMES EARLIER THIS WEEK-LAST PIR SUBMITTED. THE ISSUE IS WITH OUR TEXIUM, CT # 10012241-0500. OUR TEXIUM (FEMALE END) IS BEING CONNECTED TO THE CUSTOMER'S HALYARD C-SERIES ELASTOMERIC PUMP.....FIXED MALE SWIVEL LUER LOCK END OF THE IV LINE.... 5FU IS BEING ADMINISTERED AND HAS LEAKED BETWEEN THE CONNECTIONS. OUR TEXIUM IS BEING USED WITH ALL TYPES OF HOMECARE SETS AND APPLICATIONS, IE: BUDDY PUMP SET.....BUT THIS ISSUE OF LEAKING IS ONLY OCCURRING WITH THE C-SERIES PUMP-IV LINE.. PLEASE SEE THE ATTACHED PICTURES AS WELL. DESCRIBE PATIENT / HCP / USER IMPACT ONE OF THE PATIENTS WENT TO THE ER, THINKING THAT DUE TO THE LEAK THEY WERE NOT GETTING THEIR MEDICATION."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 TEXIUM CLOSED MALE LUER WITH FEMAILE CAP LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS A LEAKING ISSUE WHEN USING THE TEXIUM CLOSED MALE LUER WITH THE C-CERIES PUMP IV LINE. DESCRIBE CUSTOMER CONCERN THIS EVENT HAS OCCURED 7 TIMES IN THE LAST TWO DAYS AND SEVERAL TIMES EARLIER THIS WEEK-LAST PIR SUBMITTED. THE ISSUE IS WITH OUR TEXIUM, CT # 10012241-0500. OUR TEXIUM (FEMALE END) IS BEING CONNECTED TO THE CUSTOMER'S HALYARD C-SERIES ELASTOMERIC PUMP.....FIXED MALE SWIVEL LUER LOCK END OF THE IV LINE.... 5FU IS BEING ADMINISTERED AND HAS LEAKED BETWEEN THE CONNECTIONS. OUR TEXIUM IS BEING USED WITH ALL TYPES OF HOMECARE SETS AND APPLICATIONS, IE: BUDDY PUMP SET.....BUT THIS ISSUE OF LEAKING IS ONLY OCCURRING WITH THE C-SERIES PUMP-IV LINE.. PLEASE SEE THE ATTACHED PICTURES AS WELL. DESCRIBE PATIENT / HCP / USER IMPACT ONE OF THE PATIENTS WENT TO THE ER, THINKING THAT DUE TO THE LEAK THEY WERE NOT GETTING THEIR MEDICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209237 TEXIUM CLOSED MALE LUER WITH FEMAILE CAP INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION 303, INC. 10012241-0500 UNKNOWN 50885403221703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention