BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10423119 · Received August 18, 2020

    Report

    Report Number
    9616066-2020-02487
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 28, 2020
    Report Date
    July 28, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403233906
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED MICROBORE TUBING WITH PRESSURE DISK CRACKED AT ONE OF THE FEMALE LUERS. RECEIVED FROM THE CUSTOMER WAS ONE USED SUSPECT SYRINGE EXTENSION SET MODEL 10014914 LOT UNKNOWN WITH A USED EXTENSION SET MODEL 10011865 LOT UNKNOWN CONNECTED TO THE MALE LUER OF THE SUSPECT SET. A MONOJECT 10ML SYRINGE OF 0.9% SODIUM CHLORIDE LOT: 19C0494 EXP: (B)(6) 2021, WAS RECEIVED CONNECTED TO THE FEMALE LUER OF THE SUSPECT SET MODEL 10014914. THE SYRINGE HAD APPROXIMATELY 5ML OF LFUID LEFT. THE AS-RECEIVED SYRINGE EXTENSION SET SAMPLE WAS INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING, OR DAMAGES TO THE COMPONENTS. THERE WAS A CRACK ALONG THE SIDE OF THE EXTENSION SET FEMALE LUER LOCK P/N 630-01364 COMPONENT (CAVITY 20). THE LOCATION OF THE INJECTION GATE (BELOW THE WINGS/TABS) INDICATES THAT THIS FEMALE LUER WAS MANUFACTURED AFTER THE CHANGE ORDER (CO #1109132) THAT MOVED THE INJECTION GATE TO A LOWER LOCATION TO HELP MITIGATE AND PREVENT FEMALE LUER CRACKS. NO TOOL MARKINGS WERE OBSERVED AROUND THE OBSERVED DAMAGED AREA. NO ISSUE WERE OBSERVED WITH THE CONCOMITANT EXTENSION SET RECEIVED DURING INSPECTION. ALTHOUGH DAMAGE WAS OBSERVED, FUNCTIONAL TESTING WAS PERFORMED. FLUID FROM REMAINING RETURNED 10ML SYRINGE WAS PUSHED THROUGH. THE FLUID LEAKED FROM THE CRACK FEMALE LUER. NO OTHER LEAKS WERE OBSERVED DURING TESTING WITH THE USED SUSPECT SET AND CONCOMITANT SET RETURNED. EQUIPMENT USED (INSPECTION PERFORMED ON (B)(6) 2020): - RAM OPTICAL INSTRUMENTATION/EQ08204/CALIBRATION DUE DATE 5-FEB-2021 THE DEVICE HISTORY RECORD FOR SET MODEL 10014914 COULD NOT BE PERFORMED DUE TO NO LOT NUMBER BEING PROVIDED. THE CUSTOMER'S REPORT THAT THE FEMALE LUER CRACKED WAS CONFIRMED UPON VISUAL INSPECTION. THE ROOT CAUSE OF THE FEMALE LUER CRACK WAS IDENTIFIED TO BE A RESULT OF INTERNAL STRESSES CREATED DURING THE MANUFACTURING PROCESS THAT MAKE IT MORE SUSCEPTIBLE TO CHEMICAL/MECHANICAL ATTACKS AND THE PVC MATERIALS USED IN THE NEW FEMALE LUER. CORRECTIVE ACTION DOCUMENTED IN TRACKWISE CAPA PR 84753 (COMPLETED 21/FEB/2018) DRAMATICALLY REDUCED THE INTERNAL STRESSES AND MATERIAL DEGRADATION IN THE LUER AND CO #1109132 WAS ISSUED TO DOCUMENT THE IMPLEMENTATION OF THE NEW FEMALE LUER. ALTHOUGH THIS FAILURE HAS OCCURRED IN THE NEWLY IMPLEMENTED FEMALE LUER, THE CAPA¿S EFFECTIVENESS CHECK PLAN TARGETS A 50% REDUCTION IN COMPLAINTS PER MILLION AND THE CORRECTIVE ACTIONS ARE IN PLACE TO HELP MITIGATE THE FEMALE LUER CRACKS. AT THIS TIME, THIS IS CONSIDERED AN ISOLATED EVENT AND BD MANUFACTURING WILL CONTINUE TO MONITOR THIS ISSUE FOR AN INCREASE IN FREQUENCY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS SYR PSD MICROBORE TUBING WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914; BATCH NO: UNKNOWN. IT WAS REPORTED MICROBORE TUBING WITH PRESSURE DISK CRACKED AT ONE OF THE FEMALE LUERS.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH IS NOT KNOWN; (B)(6) 2020 HAS BEEN USED AS A PLACE HOLDER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SYR PSD MICROBORE TUBING WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10014914 BATCH NO: UNKNOWN. IT WAS REPORTED MICROBORE TUBING WITH PRESSURE DISK CRACKED AT ONE OF THE FEMALE LUERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886604 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION 10014914 UNKNOWN 10885403233906

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Other 10011865