BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    MDR report key: 7720630 · Received July 25, 2018

    Report

    Report Number
    9610847-2018-00230
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    July 2, 2018
    Report Date
    August 28, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851004
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX: UNKNOWN; EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF OTHER WITH LOT #7235538 REGARDING ITEM #385100. 7220530: THE LOT WAS BUILT ON QFA LINE3 FROM 10AUG2017 THRU 11AUG2017 FOR THE QUANTITY OF (B)(4). 7220533: THE LOT WAS BUILT ON QFA LINE 3 FROM 13AUG2017 THRU 17AUG2017 FOR THE QUANTITY OF (B)(4). PER REVIEW OF THE DHRS IT WAS CONCLUDED THAT ALL CHALLENGE, SET-UP AND IN-PROCESS SAMPLES (INCLUDING BUT NOT LIMITED) BOND/WELD STRENGTH AND LEAK TESTING WERE PERFORMED THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE DISCLOSED AS IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THESE LOTS THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. RECEIVED ONE UNUSED UNIT ALONG WITH AN OPENED PACKAGE FROM LOT NUMBER 7235538. THE Q-SYTE WAS RECEIVED IN 2 PORTIONS (TOP AND BOTTOM BODY). EVIDENCE OF AN ADEQUATE WELD WAS OBSERVED AT THE RIMS OF BOTH THE TOP AND BOTTOM BODIES. THIS IS AN INDICATION THAT A BOND (WELD) WAS PROVIDED DURING THE MANUFACTURING PROCESS. A FAILURE MODE ASSOCIATED WITH THE RETURNED SAMPLE DID NOT INDICATE THAT MANUFACTURING PROCESS INTRODUCED THE DAMAGE OBSERVED. EXTERNAL FORCES MOST LIKELY CONTRIBUTED TO THE DAMAGE OBSERVED. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A MANUFACTURING RELATED ROOT CAUSE COULD NOT BE IDENTIFIED. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE HAD A CRACKED HOUSING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). HOSPITAL. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE HAD A CRACKED HOUSING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559455 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7235538 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other