BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7602813 · Received June 14, 2018

    Report

    Report Number
    9610847-2018-00188
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 21, 2018
    Report Date
    July 11, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: 7212772: THE LOT WAS BUILT ON (B)(4) FROM 6AUG2017 THRU 8AUG2017 FOR THE QUANTITY OF (B)(4) EA. 7212775: THE LOT WAS BUILT ON (B)(4) FROM 8AUG2017 THRU 10AUG2017 FOR THE QUANTITY OF (B)(4) EA. ALL REQUIRED CHALLENGE, SET-UP AND IN-PROCESS SAMPLES WERE PERFORMED PER PROCEDURE AND 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 THIS LOTS THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. QN / SAP DATABASE REVIEW FINDINGS: NO QN¿S WERE INITIATED DURING THE PRODUCTION OF THE SUB-ASSEMBLY LOT IDENTIFIED RELATED TO THIS INVESTIGATION THE PEURA (END USER RISK ANALYSIS) RM5699 REV 5 VERSION D WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL ANALYSIS OBSERVATIONS AND TESTING: RECEIVED A TOTAL OF 3 Q-SYTE UNITS; 2 OF THE UNITS UNUSED AND WERE RECEIVED WITHIN SEALED PACKAGES AND ONE UNIT WAS USED AND WAS RECEIVED WITHIN A PAPER BAG WITH HANDWRITTEN WORDS ON IT. VISUAL/MICROSCOPIC EXAMINATION: UNIT 1 (USED): ¿ THE SEPTUM WAS MOLDED USING THE 32 CAVITY MOLD. ¿ DAMAGE (TEARS) WAS OBSERVED ABOVE THE SLIT OF THE TOP SEPTUM ¿ THE SLIT WAS PRESENT PER SPECIFICATIONS ¿ THE SEPTUM WAS NOT PUSHED INTO THE ADAPTER UNITS 2 AND 3 (UNUSED): BOTH OF THE SEPTUMS WERE MOLDED USING 32 CAVITY MOLD. NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON THE TOP DISKS AND THE SLITS WERE PRESENT PER SPECIFICATION. THE SEPTUMS WERE NOT PUSHED INTO THE ADAPTERS. ALL UNITS: ¿ DURING PROBE INSERTION IT WAS CONFIRMED BOTH THE TOP AND BOTTOM SLITS WERE PRESENT ¿ THE WATER FLOWED FREELY INTO THE Q-SYTE UNITS AND OUT WITH NO OBSTRUCTION. ¿ THE FLOW TEST PASSED PER SPECIFICATION OF 1 LITER/HOUR WITH THE FOLLOWING RESULTS: 1. UNIT 1 = 26.53 L/H 2. UNIT 2 = 32.73 L/H 3. UNIT 3 = 29.78 L/H INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO, THE TOP DISK SLIT ON UNIT 1 REVEALED DAMAGE (TEAR). CONCLUSIONS: ¿ THE FLOW RATE TEST MET MANUFACTURING SPECIFICATIONS ¿ THE WATER FLOWED THROUGH THE UNITS ¿ THE TOP SLITS REVEALED DAMAGE (TEARS) (UNIT 1) ¿ THE SEPTUMS WERE NOT PUSHED INTO THE ADAPTERS. ALTHOUGH THE FLOW RATE RESULT PASSED PER SPECIFICATIONS, THE SLIT TEAR (OBSERVED ON UNIT 1) COULD BE A CONTRIBUTIVE FACTOR FOR THE FAILURE OF FLOW RATE (IF THE USER WAS TRYING TO INSERT DEVICES THROUGH THE TEAR INSTEAD OF THROUGH THE SLIT), THE TEAR OBSERVED ON THE TOP DISK IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS. COMMENT: 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 WILL NOT BE INITIATED AT THIS TIME. A DEFINITE ROOT CAUSE THAT CAUSED THE DAMAGE OBSERVED WITH THE RETURNED UNIT COULD NOT BE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A NURSE FOUND THE SEPTUM OF A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE PUSHED INTO THE ADAPTER AFTER USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A NURSE FOUND THE SEPTUM OF A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE PUSHED INTO THE ADAPTER AFTER USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442834 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE Q-SYTE SPLIT SEPTUM FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7209846 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other