BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7658457 · Received July 3, 2018

    Report

    Report Number
    9610847-2018-00192
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 12, 2018
    Report Date
    August 15, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851003
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED ONE Q-SYTE UNIT WITH NO PACKAGING MATERIAL. THE UNIT WAS RECEIVED ALONG WITH SPECIMEN CONTAINER. -DHR REVIEW WAS PERFORMED ON THE FOLLOWING SUB ASSEMBLY LOT NUMBERS: 7143620 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3 FROM JUNE 1, 2017 THRU JUNE 3, 2017. 7143622 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3 FROM JUNE 5, 2017 THRU JUNE 7, 2017 7152682 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2 FROM JUNE 23, 2017 THRU JUNE 25, 2017. 7152691 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3 FROM JUNE 14, 2017 THRU JUNE 16, 2017. 7160875 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2 FROM JUNE 25, 2017 THRU JUNE 27, 2017. REVIEW OF THE DHRS REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW 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 VISUAL/MICROSCOPIC EXAMINATION: DAMAGE (TEARS) WAS OBSERVED ON THE SEPTUM TOP DISK SLIT DAMAGE (TEARS) WAS OBSERVED ON THE COLUMN WALL. DAMAGE (TEARS) WAS OBSERVED ON THE BOTTOM SLIT OF SEPTUM (DISSECTED IT FOR EVALUATION). WATER LEAK TEST (MM-110): ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE EXTENSION THE Q-SYTE, LEAKAGE WAS OBSERVED ON THE ACTUATED POSITION, WATER LEAKED OUT OF THE VENT HOLE. INVESTIGATION CONCLUSION: ROOT CAUSE WAS INDETERMINATE.

    Additional Manufacturer Narrative · 0

    CORRECTION: 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: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499733 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE Q-SYTE FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7178870 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other