BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7699478 · Received July 18, 2018

    Report

    Report Number
    9610847-2018-00219
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 26, 2018
    Report Date
    August 24, 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

    RECEIVED A TOTAL OF 2 Q-SYTE UNITS ALONG WITH AN EXTENSION SET. ONE OF THE UNITS WAS RECEIVED WITHIN A SEALED PACKAGE, THE OTHER WITHOUT PACKAGING MATERIAL. DHR REVIEW: 7180763; WAS BUILT ON QFA LINE3, FROM 11JUL2017 THRU 13JUL2017 FOR THE QUANTITY OF 180,000EA. 7191939; WAS BUILT ON QFA LINE3, FROM 15JUL2017 THRU 17JUL2017 FOR THE QUANTITY OF 180,000EA. 7191944; WAS BUILT ON QFA LINE2, FROM 14JUL2017 THRU 16JUL2017 FOR THE QUANTITY OF 180,000EA. ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. SET-UP AND IN-PROCESS SAMPLES (INCLUDING BUT NOT LIMITED) BOND/WELD STRENGTH, LEAK AND FOR FOREIGN-NON-FOREIGN 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 THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL/MICROSCOPIC EXAMINATION: UNIT 1- NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE Q-SYTE. UNIT 2- DAMAGE (TEARS) WAS OBSERVED ON THE SLIT OF THE SEPTUM TOP DISK. DAMAGE (TEARS) WAS OBSERVED ON THE COLUMN WALL. DAMAGE (TEARS) WAS OBSERVED ON THE SLIT OF THE SEPTUM BOTTOM DISK (DISSECTED FOR EVALUATION). WATER LEAK TEST (MM-110): THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE WHERE THE Q-SYTE UNITS WERE CONNECTED: UNIT 1 - NO LEAKAGE WAS OBSERVED ON EITHER THE ACTUATED OR THE UNACTUATED POSITIONS. UNIT 2 ¿ NO LEAKAGE WAS OBSERVED WHEN TESTED ON THE UNACTUATED POSITION. LEAKAGE WAS OBSERVED WHEN THE UNIT WAS TESTED ON THE ACTUATED POSITION. THE SOURCE OF THE LEAKAGE WAS THE TEAR OF THE COLUMN WALL LEAKING THROUGH THE VENT HOLE. ROOT CAUSE FOR THIS INCIDENT IS INDETERMINATE. A DEFINITE SOURCE THAT CAUSED DAMAGE TO THE COLUMN TEAR; WHICH COULD HAVE CONTRIBUTED TO THE LEAKAGE, COULD NOT BE ESTABLISHED. THE FAILURE MODES NORMALLY ATTRIBUTED TO THESE TYPES OF DAMAGE ARE INCORRECT USAGE OR EXCESSIVE ACTUATIONS. A MANUFACTURING RELATED ROOT CAUSE COULD NOT BE IDENTIFIED. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICATION LEAKED FROM THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. EVENT OCCURRED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICATION LEAKED FROM THE BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. EVENT OCCURRED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

    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 THAT MEDICATION LEAKED FROM THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. EVENT OCCURRED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542833 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7209836 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other