BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM WITH 15 CM (6 IN.)

    MDR report key: 6908969 · Received October 2, 2017

    Report

    Report Number
    9610847-2017-00107
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 11, 2017
    Report Date
    November 2, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CORRECTIVE ACTION STATEMENT IS APPROVED/AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY DESIGNATED COMPLAINT HANDLING UNIT. INVESTIGATION COMPLETED BY: (B)(6). PIR #: 137821-140001 ¿ MDR. PART #: 385102 Q-SYTE EXT. SET LUER LOK 6IN MICRO BORE. LOT #: 6153614 . SUB-ASSEMBLY LOT: 6158831 (MATERIAL 8004149). COMPLAINT: LEAKAGE. CUSTOMER VERBATIM: NURSE FOUND LEAKAGE OCCURRED FROM THE CONNECTION OF THE EXTENSION TUBING & Q-SYTE. 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 (MDR). THIS INVESTIGATION IS CLASSIFIED AS MDR. FINDINGS: DHR REVIEW WAS PERFORMED ON THE SUB-ASSEMBLY MATERIAL 8004149 LOT NUMBER 6158831. A TOTAL OF (B)(4) UNITS WERE BUILT ON QFA LINE 4 STARTING ON JUNE 7, 2016 THROUGH JUNE 09, 2016. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND 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. SET UP AND IN PROCESS SAMPLES (INCLUDING BUT NOT LIMITED) FOR LEAKAGE, SLIT QUALITY AND BOND/WELD STRENGTH WERE PERFORMED THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. QN / SAP DATABASE REVIEW: NO. REASON: A REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR LEVEL A INVESTIGATIONS PER CPR ¿ 071. THE PEURA (END USER RISK ANALYSIS): YES. REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: VISUAL ANALYSIS. OBSERVATIONS AND TESTING: RECEIVED TWO USED Q-SYTE WITH EXTENSION SETS WITHIN OPEN PACKAGES. VISUAL/MICROSCOPIC EVALUATION: UNIT 1: THE SEPTUM WAS MOLDED USING THE 16 CAVITY MOLD. NO DAMAGE WAS OBSERVED ON THE SEPTUM TOP DISK/SLIT. NO COLUMN DAMAGE WAS OBSERVED ON ANY OF THE SIDES OF THE COLUMN. NO DAMAGE WAS OBSERVED ON THE THREADS OF THE Q-SYTE UNIT (MALE LUER). NO DAMAGE WAS OBSERVED ON THE THREADS OF THE EXTENSION SET (FEMALE LUER). CONNECTION WAS SECURE. UNIT 1: THE SEPTUM WAS MOLDED USING THE 16 CAVITY MOLD. NO DAMAGE WAS OBSERVED ON THE SEPTUM TOP DISK/SLIT. NO COLUMN DAMAGE WAS OBSERVED ON ANY OF THE SIDES OF THE COLUMN. NO DAMAGE WAS OBSERVED ON THE THREADS OF THE Q-SYTE UNIT (MALE LUER). NO DAMAGE WAS OBSERVED ON THE THREADS OF THE EXTENSION SET (FEMALE LUER). CONNECTION WAS SECURE. WATER LEAK TEST (MM-110): UNITS 1 AND 2: ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE EXTENSION SET, NO LEAKAGE WAS OBSERVED ON EITHER THE ACTUATED OR THE UNACTUATED POSITIONS. ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE Q-SYTE UNITS, NO LEAKAGE WAS OBSERVED ON EITHER THE ACTUATED OR THE UNACTUATED POSITIONS. TEST DESCRIPTION: METHOD NO, RESULTS. VISUAL/MICROSCOPIC: N/A, SEE OBSERVATIONS AND TESTING. WATER LEAK TEST: MM-110, SEE OBSERVATIONS AND TESTING. COLUMN TEAR ASSESSMENT: VTP-31, SEE OBSERVATIONS AND TESTING. BOTTOM SEPTUM EVALUATION : N/A, SEE OBSERVATIONS AND TESTING. SLIT LOCATION AND DIMENSIONS: QCPA-13, SEE OBSERVATIONS AND TESTING. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES. NO DAMAGE OR LEAKAGE WAS OBSERVED DURING THE EVALUATION OF THE RECEIVED UNITS. INVESTIGATION CONCLUSION CONCLUSIONS: THE DEFECT OF LEAKAGE COULD NOT BE CONFIRMED. THE UNITS WERE TESTED WITH AND WITHOUT EXTENSION SETS AND NO LEAKAGE WAS OBSERVED. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO. THE CUSTOMER¿S EXPERIENCE COULD NOT BE CONFIRMED. THE UNITS WERE TESTED WITH AND WITHOUT EXTENSION SETS AND NO LEAKAGE WAS OBSERVED. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO. THE DEFECT OF LEAKAGE EXPERIENCED BY THE CUSTOMER COULD NOT BE REPRODUCED IN THE LABORATORY ENVIRONMENT. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE DESCRIPTION: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION COULD NOT BE CONFIRMED OR REPLICATED. COMMENT: AN INSTRUCTION PAMPHLET IS PROVIDED WITH Q-SYTE PRODUCT. THIS INFORMATION DOCUMENTS THE POTENTIAL FAILURE MODES OF THIS DEVICE IF NOT USED PROPERLY.

    Description of Event or Problem · 1

    THIS COMPLAINT IS MDR REPORTABLE. IT WAS REPORTED THAT A BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM WITH 15 CM (6 IN.) SMALL BORE EXTENSION SET, FIXED NUT, WAS FOUND LEAKING DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686504 BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM WITH 15 CM (6 IN.) LUER ACCESS FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 6153614

    Patients

    Seq Age Sex Outcome Treatment
    1 Other