BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7001547 · Received November 3, 2017

    Report

    Report Number
    9610847-2017-00138
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    September 20, 2017
    Report Date
    October 23, 2017
    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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(4). INVESTIGATION: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. ONE OF THE RETURNED SAMPLES INSPECTED SHOWED A PORTION OF THE SEPTUM TOP DISK WAS MISSING AND DAMAGE (TEARING) WAS OBSERVED ON ONE SIDE. ON THE SECOND SAMPLE, IT WAS OBSERVED THAT THE DISK WAS LIFTED FROM THE RIM OF THE Q-SYTE NECK. EVEN THOUGH THE LEAK TEST COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE UNIT, (TEAR AT TOP DISK), THE DAMAGE OBSERVED COULD HAVE POTENTIALLY CAUSED THE UNIT TO LEAK. THERE WERE NO INDICATIONS THAT THE REPORTED ISSUE RESULTED FROM THE MANUFACTURING PROCESS. INVESTIGATION CONCLUSION: DHR REVIEW WAS PERFORMED ON THE SUB-ASSEMBLY LOT NUMBERS 6246664 AND 6230758. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATIONS, 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. RECEIVED ONE Q-SYTE UNIT WITHIN AN OPEN PACKAGE FROM LOT 6244832. THE UNIT WAS OF A 16 CAVITY MOLD. OBSERVED A PORTION OF THE SEPTUM TOP DISK WAS MISSING AND DAMAGE (TEARING) WAS OBSERVED ON ONE SIDE AND THE DISK WAS LIFTED FROM THE RIM OF THE Q-SYTE NECK ON THE OTHER SIDE. A PORTION OF THE SEPTUM TOP DISK WAS MISSING AND DAMAGE (TEARING) WAS OBSERVED ON ONE SIDE AND THE DISK WAS LIFTED FROM THE RIM OF THE Q-SYTE NECK ON THE OTHER. CONCLUSIONS: ALTHOUGH THE LEAK TEST WAS NOT CONFIRMED DUE TO THE CONDITION OF THE UNIT (TEAR AT TOP DISK), THE DAMAGE OBSERVED COULD CAUSE LEAKAGE. ALTHOUGH THE LEAK TEST WAS NOT CONFIRMED DUE TO THE CONDITION OF THE UNIT (TEAR AT TOP DISK), THE DAMAGE OBSERVED COULD CAUSE LEAKAGE. ROOT CAUSE DESCRIPTION: THE EVALUATION OF THE SEPTUM REVEALED EVIDENCE OF ADHESIVE AND SEPTUM DEPOSITS. THIS IS AN INDICATION THAT A BOND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED DURING USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779819 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LUER ACCESS SPLIT SEPTUM FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6244832 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other