BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7321428 · Received March 7, 2018

    Report

    Report Number
    9610847-2018-00039
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 8, 2018
    Report Date
    April 3, 2018
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING USE, A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS FOUND LEAKING WHEN "APPLYING PRESSURE FROM THE BOTTOM OF THE Q-SITE, DRUG SPOUTED." THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REQUIRED. MEDICAL DEVICE BRAND NAME: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, MEDICAL DEVICE TYPE: FPA, COMMON DEVICE NAME: Q-SYTE, UDI #: (B)(4), 510K: K013621. NEW CATALOG # PROVIDED 385100 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: NO. REASON: ALTHOUGH THIS INVESTIGATION IS CLASSIFIED AS MDR THE LOT NUMBER RELATED TO THIS ACCOUNT IS UNKNOWN. FINDINGS: N/A. QN / SAP DATABASE REVIEW: NO. REASON: THE LOT NUMBER FOR THIS INVESTIGATION IS UNKNOWN. FINDINGS: N/A. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED ONE USED Q-SYTE UNIT ATTACHED TO A 3 WAY VALVE ON THE MALE END AND TO A SYRINGE TO THE FEMALE END. VISUAL/MICROSCOPIC EVALUATION: Q-SYTE: THE SEPTUM WAS MOLDED USING THE 32 CAVITY MOLD. NO DAMAGE WAS OBSERVED ON THE SEPTUM TOP DISK. NO COLUMN DAMAGE WAS OBSERVED. WATER LEAK TEST (MM-110): O ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE Q-SYTE UNIT, NO LEAKAGE WAS OBSERVED ON EITHER THE ACTUATED NOR THE UN-ACTUATED POSITIONS. O ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO ONE OF THE ENDS OF THE 3 WAY VALVE WITH THE Q-SYTE UNIT STILL CONNECTED TO IT, LEAKAGE OCCURRED FROM THE NECK ON ONE OF THE VALVE¿S PORTS 3 WAY VALVE: THE 3 WAY VALVE REVEALED DAMAGE ON THE POLYCARBONATE MATERIAL ON ONE OF ITS PORTS. 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. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES. THE Q-SYTE UNIT RECEIVED FOR EVALUATION MET MANUFACTURING SPECIFICATIONS. CONCLUSIONS: THE Q-SYTE UNIT DID NOT LEAK ON NEITHER THE ACTUATED NOR THE UN-ACTUATED POSITIONS, LEAKAGE WAS OBSERVED THROUGH THE DAMAGE ON THE 3 WAY VALVE RECEIVED ALONG WITH THE UNIT. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO. NO LEAKAGE WAS CONFIRMED. THE Q-SYTE UNIT DID NOT LEAK DURING TESTING. LEAKAGE WAS OBSERVED THROUGH THE DAMAGE ON THE 3 WAY VALVE RECEIVED ALONG WITH THE Q-SYTE. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO. THE FAILURE EXPERIENCED BY THE CUSTOMER COULD NOT BE REPRODUCED. THE Q-SYTE RECEIVED DID NOT LEAK DURING THE TESTING PERFORMED IN THE LABORATORY. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. NOGALES CONCLUSION, BASED ON SAMPLE INVESTIGATION, WE HAVE DETECTED THAT STOPCOCKS SAMPLE RECEIVED IS NOT MANUFACTURED HERE IN NOGALES BD PLANT. INVESTIGATION CONCLUSION: ROOT CAUSE. RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. NOTE: LEAKAGE WAS OBSERVED THROUGH THE DAMAGE ON THE 3 WAY VALVE RECEIVED ALONG WITH THE Q-SYTE. THE VALVE WILL BE FORWARDED TO NOGALES (PLANT) FOR FURTHER EVALUATION. 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 · 0

    IT WAS REPORTED THAT DURING USE, A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE WAS FOUND LEAKING WHEN "APPLYING PRESSURE FROM THE BOTTOM OF THE Q-SITE, DRUG SPOUTED." THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REQUIRED.

    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 DURING USE, A BD CONNECTA¿ STOPCOCK WAS FOUND LEAKING WHEN "APPLYING PRESSURE FROM THE BOTTOM OF THE Q-SITE, DRUG SPOUTED." THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165509 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE Q-SYTE FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other