BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9310346 · Received November 12, 2019

    Report

    Report Number
    9610847-2019-00673
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 28, 2019
    Report Date
    January 7, 2020
    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
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9144786 D.4. MEDICAL DEVICE EXPIRATION DATE: 4/30/2024 H.4. DEVICE MANUFACTURE DATE: 5/24/2019 D.4. MEDICAL DEVICE LOT #: 9031822 D.4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2023 H.4. DEVICE MANUFACTURE DATE: 1/31/2019 D.4. MEDICAL DEVICE LOT #: 9031818 D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2023 H.4. DEVICE MANUFACTURE DATE: 1/31/2019. H.6. INVESTIGATION SUMMARY: RECEIVED A TOTAL OF 6 UNITS INSIDE SPECIMEN BOTTLES ALONG WITH AN EMPTY/OPEN PACKAGE FROM LOT 9144786. THE UNITS WERE RECEIVED AS FOLLOWS: LOT 9144786: 2 USED UNITS AND 1 UNUSED UNIT. LOT 9031822: 1 USED UNIT. LOT 9031818: 1 USED UNIT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. VISUAL EXAMINATION: UNITS 1-4 (USED) UNITS RECEIVED REVEALED DAMAGE (TEARS) ON THE SLIT OF THE SEPTUM TOP DISK. ALL OF THE USED UNITS (1-5) RECEIVED REVEALED DAMAGE (TEARS) ON THE SLIT OF THE SEPTUM BOTTOM DISK. NONE OF THE RECEIVED UNITS HAD DAMAGE ON THE COLUMN WALL. NO PHYSICAL-MECHANICAL DAMAGE WAS FOUND ON ANY OF THE COMPONENTS OF THE UNUSED UNIT RECEIVED. WATER-LEAK TEST: ALL UNITS WERE TESTED IN THE ACTUATED AND THE UN-ACTUATED POSITIONS. NO LEAKAGE OCCURRED ON ANY OF THE RECEIVED UNITS. CONCLUSION(S): NOT DETERMINED THE FAILURE EXPERIENCED BY THE CUSTOMER COULD NOT BE CONFIRMED OR REPLICATED IN THE LABORATORY. THE DAMAGE OBSERVED ON THE SEPTUMS SLITS IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS DISCONNECTED FROM THE ADAPTER AFTER USE, BLOOD LEAKED FROM THE VALVE CENTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "THE QSYTE IS SCREWED TO THE BACK OF THE INSYTE BLOOD CONTROL CATHETER BASE. THEN, A LUER VACUTAINER ADAPTER IS INSERTED TO COLLECT BLOOD FROM THE CATHETER. WHEN DISCONNECTED, THE QYST CONTINUOUSLY LEAKS AND BLOOD FLOWS THROUGH THE CENTER OF THE VALVE."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS DISCONNECTED FROM THE ADAPTER AFTER USE, BLOOD LEAKED FROM THE VALVE CENTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE QSYTE IS SCREWED TO THE BACK OF THE INSYTE BLOOD CONTROL CATHETER BASE. THEN, A LUER VACUTAINER ADAPTER IS INSERTED TO COLLECT BLOOD FROM THE CATHETER. WHEN DISCONNECTED, THE QYST CONTINUOUSLY LEAKS AND BLOOD FLOWS THROUGH THE CENTER OF THE VALVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103185 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other