BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7355603 · Received March 20, 2018

    Report

    Report Number
    9610847-2018-00057
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    February 28, 2018
    Report Date
    April 18, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, TEARS WERE OBSERVED ON THE TOP AND BOTTOM OF THE SEPTUM AND WITHIN THE COLUMN. A LEAKAGE TEST DID NOT RESULT IN LEAKAGE IN EITHER THE UN-ACTUATED OR ACTUATED POSITIONS. DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: REVIEW WAS CONDUCTED ON THE SUB-ASSEMBLY (Q-SYTE) LOT NUMBERS WHICH DISCLOSED THE FOLLOWING: LOT 7131944; WAS BUILT ON QFA LINE 2, FROM 24MAY2017 THRU 26MAY2017 FOR THE QUANTITY OF 180,000EA. LOT 7131947; WAS BUILT ON QFA LINE 3, FROM 21MAY017 THRU 23MAY2017 FOR THE QUANTITY OF 180,000EA. REVIEW OF THE DHRS DISCLOSED NO INDICATION OF THE ALLEGED DEFECT, AS THERE WAS ONE NON-RELATED QN INITIATED AND NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THESE LOTS THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT AS STATED IN THE PIR. PER REVIEW OF THE DHRS IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. SET-UP AND IN-PROCESS SAMPLES (INCLUDING BUT NOT LIMITED) BOND/WELD STRENGTH AND LEAK TESTING WERE PERFORMED THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE DISCLOSED AS IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THESE LOTS THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SAP (QN) DATABASE REVIEW DISCLOSED ONE NON-RELATED QN AND NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT ASSOCIATED WITH THE SUB-ASSEMBLY LOT NUMBERS FOR THIS INCIDENT. OBSERVATIONS AND TESTING: RECEIVED ONE USED Q-SYTE UNIT ACCOMPANIED WITHIN AN OPENED PACKAGE FROM LOT 7178866. THE UNIT WAS INTACT AND HAD TRACES OF DRIED MEDIA PRESENT. VISUAL EXAMINATION: SEPTUM IS OF A 16 CAVITY MOLD. THERE WERE NO ANOMALIES OR DAMAGE TO THE EXTERNAL AREAS OF THE Q-SYTE UNIT; TOP BODY OR BOTTOM BODY (POLYCARBONATE). MICROSCOPIC EVALUATION: OBSERVED THE SLIT WAS CENTERED IN ITS CORRECT POSITION ON THE SEPTUM TOP DISK AND THERE WAS A TEAR AT EACH END OF THE SLIT. SEPTUM COLUMN TEAR ASSESSMENT: THERE WERE TWO TEARS TO THE COLUMN WALL (COLUMN TEAR); OPPOSITE EACH OTHER. BOTTOM SEPTUM EVALUATION: OBSERVED THE SLIT AT THE SEPTUM BOTTOM DISK WAS IN ITS¿ CORRECT POSITION (CENTERED) AND THERE WAS A TEAR AT EACH END OF THE SLIT. WATER LEAK TEST FOR ACTUATED AND UN-ACTUATED Q-SYTE: LEAKAGE DID NOT OCCUR FROM ANY AREA OF THE UNIT WHEN LEAK TESTED IN BOTH THE UN-ACTUATED AND ACTUATED POSITIONS. THE FINDINGS IN THIS INCIDENT WERE INDICATIVE THAT THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS FOR THE FAILURE STATED IN THE PIR. THE Q-SYTE WAS OBSERVED TO HAVE A TEAR AT EACH END OF THE SLIT AT THE SEPTUM TOP AND BOTTOM DISK AND TWO COLUMN TEARS; THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS AND EXTRANEOUS FORCE. CONCLUSIONS: THEREFORE, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT NOTED IN THE PIR. ROOT CAUSE FOR THIS INCIDENT IS INDETERMINATE. A DEFINITE SOURCE THAT CONTRIBUTED TO THE TEAR(S) AT THE END OF THE SLIT OF THE SEPTUM TOP AND BOTTOM DISK AND THE COLUMN TEARS COULD NOT BE ESTABLISHED. AN INSTRUCTION PAMPHLET IS PROVIDED WITH Q-SYTE PRODUCT. THIS INFORMATION DOCUMENTS THE POTENTIAL FAILURE MODES OF THIS DEVICE IF NOT USED PROPERLY. A FORMAL CORRECTIVE ACTION HAS NOT BEEN INITIATED AT THIS TIME. A DEFINITE MANUFACTURING RELATED ROOT CAUSE COULD NOT BE ESTABLISHED. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE WAS FOUND WHEN USING A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194776 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE Q-SYTE FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7178866 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other