BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7138402 · Received December 21, 2017

    Report

    Report Number
    9610847-2017-00203
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 27, 2017
    Report Date
    January 23, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, TEARS WERE OBSERVED ON THE TOP DISK AND BOTTOM DISK OF THE SEPTUM. A WATER LEAK TEST SHOWED NO LEAKAGE IN EITHER THE ACTUATED OR THE UNACTUATED POSITIONS. A DEFINITE SOURCE THAT CONTRIBUTED TO THE TEARS COULD NOT BE ESTABLISHED, THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS. THE DEFECT OF LEAKAGE COULD NOT BE CONFIRMED DURING THE PERFORMANCE OF THE WATER-LEAK TEST. THE UNIT DID NOT LEAK WHEN TESTED BY ITSELF, WITH THE EXTENSION SET OR DURING THE FLUID TEST. ALL CONNECTIONS WERE SUCCESSFUL. FINDINGS: A TOTAL OF (B)(4) UNITS WERE BUILT ON QFA LINE 4 FROM (B)(6) 2016 TO (B)(6) 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. REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR LEVEL A INVESTIGATIONS PER (B)(4). RECEIVED ONE USED Q-SYTE WITH NO PACKAGING MATERIAL ALONG WITH A BRAUN 20ML LUER LOCK SYRINGE AND A MEDRAD STELLANT EXTENSION SET BOTH ON OPEN PACKAGES. VISUAL/MICROSCOPIC EVALUATION: THE SEPTUM WAS MOLDED USING THE 16 CAVITY MOLD DAMAGE (TEAR) WAS OBSERVED ON THE SEPTUM TOP DISK/SLIT (SEE PHOTO 193928-203569-2). DAMAGE (TEAR) WAS OBSERVED ON THE SEPTUM BOTTOM DISK/SLIT (UNIT WAS DISASSEMBLED AFTER WATER/LEAK TEST) NO DAMAGE WAS OBSERVED ON THE COLUMN WALL WATER LEAK TEST (MM-110): 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 OR THE UNACTUATED POSITIONS. ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE EXTENSION SET WITH THE Q-SYTE CONNECTED TO IT AND PERFORMED THE TEST. CONNECTIONS WERE SUCCESSFUL AND NO LEAK WAS OBSERVED. FLUID TEST: THE RECEIVED SYRINGE WAS FILLED WITH WATER-FOOD COLORING SOLUTION AND CONNECTED IT TO THE Q-SYTE UNIT. THE CONNECTION WAS SUCCESSFUL AND THE LIQUID FLOWED OUT THE MALE END OF THE Q-SYTE. NO LEAKAGE WAS OBSERVED ON THE CONNECTION. DAMAGE (TEARS) WAS OBSERVED ON THE SLIT OF THE TOP AND BOTTOM SEPTUM DISKS. CONCLUSIONS: THE DEFECT OF LEAKAGE COULD NOT BE CONFIRMED DURING THE PERFORMANCE OF THE WATER-LEAK TEST. THE UNIT DID NOT LEAK WHEN TESTED BY ITSELF, WITH THE EXTENSION SET OR DURING THE FLUID TEST. ALL CONNECTIONS WERE SUCCESSFUL. THE CUSTOMER¿S EXPERIENCE COULD NOT BE CONFIRMED DURING THE TESTING PERFORMED ON THE RECEIVED UNIT. 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. CONCLUSION: ROOT CAUSE A DEFINITE SOURCE THAT CONTRIBUTED TO THE TEARS (TOP-BOTTOM DISKS) COULD NOT BE ESTABLISHED, THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS. THE DEFECT OF LEAKAGE COULD NOT BE CONFIRMED DURING THE PERFORMANCE OF THE WATER-LEAK TEST. THE UNIT DID NOT LEAK WHEN TESTED BY ITSELF, WITH THE EXTENSION SET OR DURING THE FLUID TEST. ALL CONNECTIONS WERE SUCCESSFUL. 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'S 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 A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916251 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. 7026506 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other