BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7342167 · Received March 15, 2018

    Report

    Report Number
    9610847-2018-00046
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 22, 2018
    Report Date
    April 4, 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
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: COMPLAINT: LEAKAGE MALE LUER CONNECTION. EVENT DESCRIPTION: BD Q-SYTE WAS CONNECTED TO EXTENSION LINE, DURING INFUSION LEAKAGE WAS COMING THROUGH CONNECTION, THE MEDICINE IS ALBURNIN. LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE. FINDINGS: DHR REVIEW WAS PERFORMED ON THE SUB-ASSEMBLY LOT NUMBERS. 7143624 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 3, FROM JUN 6, 2017 THROUGH JUN 8, 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. 7152681 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM JUN 21, 2017 THROUGH JUN 23, 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. QN / SAP DATABASE REVIEW: NO. REASON: QN/SAP DATABASE REVIEW IS NOT REQUIRED FOR LEVEL A PER (B)(4), FINDINGS: N/A. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED ONE USED Q-SYTE UNIT ATTACHED AN EXT. LINE CONNECTED TO THE MALE CONNECTOR AND A BD PLASTIPAK SYRINGE TO THE FEMALE END ((B)(4)). VISUAL/MICROSCOPIC EVALUATION: TRACES OF MEDICINE WAS OBSERVED ON THE Q-SYTE BODY AND TOP DISK. THE SEPTUM WAS MOLDED USING THE 16 CAVITY MOLD. OBSERVED THE SYRINGE HAD LEFT A CORE ON THE TOP DISK AND DAMAGE (SCRAPE) WAS PRESENT. DAMAGE (TEARS) WAS OBSERVED ON THE SEPTUM TOP DISK. DAMAGE (TEARS) WAS OBSERVED ON THE COLUMN WALL. DAMAGE (TEARS) WAS OBSERVED ON THE SLIT OF THE SEPTUM BOTTOM DISK. WATER LEAK TEST ((B)(4)): ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE Q-SYTE UNIT, NO LEAKAGE WAS OBSERVED ON THE UN-ACTUATED POSITION. WHEN THE Q-SYTE UNIT WAS TESTED IN THE ACTUATED POSITION LEAKAGE OCCURRED. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO. DAMAGE (TEAR) WAS OBSERVED ON THE TOP, BOTTOM AND COLUMN WALL AND THE UNIT LEAKED WHEN TESTED ON THE ACTUATED POSITION. CONCLUSIONS: THE DEFECT OF LEAKAGE IS CONFIRMED. THE UNIT LEAKED WHEN TESTED ON THE ACTUATED POSITION. INVESTIGATION CONCLUSION: ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. A DEFINITE SOURCE THAT CAUSED THE COLUMN AND SLIT TEARS COULD NOT BE ESTABLISHED, THE COLUMN TEAR COULD CONTRIBUTE TO LEAKAGE. LEAKAGE DUE TO A COLUMN TEAR IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS. IN-PROCESS INSPECTIONS ARE CONDUCTED DURING THE MANUFACTURING PROCESS TO IDENTIFY PROCESS CHANGES THAT COULD CONTRIBUTE DAMAGE. COMMENT: AN INSTRUCTION PAMPHLET IS PROVIDED WITH Q-SYTE PRODUCT. THIS INFORMATION DOCUMENTS THE POTENTIAL FAILURE MODES OF THIS DEVICE IF NOT USED PROPERLY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED FROM A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184767 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE Q-SYTE FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7178873 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other