BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7511678 · Received May 14, 2018

    Report

    Report Number
    1710034-2018-00218
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    April 26, 2018
    Report Date
    July 23, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    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

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW: AS THIS COMPLAINT WAS AN MDR; DHR REVIEW WAS PERFORMED ON LOT NUMBER 7052677: 7052677 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 1, FROM FEBRUARY 21, 2017 THRU FEBRUARY 23, 2017. 7094618 ¿ THIS LOT NUMBER WAS BUILT ON QFA LINE 2, FROM APRIL 9, 2017 THRU APRIL 12, 2017. REVIEW OF THE DHRS REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE 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 THE PEURA (END USER RISK ANALYSIS): YES REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: 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 ONE UNUSED Q-SYTE UNIT FROM THE LOT NUMBER 7052677 OR 7094618. THE Q-SYTE UNIT WAS PERMANENTLY BONDED TO THE EXTENSION SET. VISUAL/MICROSCOPIC EXAMINATION: THE SEPTUM WAS MOLDED USING THE 16-CAVITY MOLD. SEPTUM TOP DISK WAS DAMAGE. SMALL PIECE OF THE SEPTUM WAS TORN FROM THE RIM OF THE TOP BODY THAT GOES DOWN INTO THE COLUMN WALL. THE RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS WAS EVIDENT ON THE RIM OF THE TOP BODY. INVESTIGATION CONCLUSION: ROOT CAUSE RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE ¿ THE EVALUATION OF THE SEPTUM DAMAGE/DEFECTIVE LOCATIONS REVEALED EVIDENCE OF RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS. THIS IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. THE Q-SYTE UNIT WAS PERMANENTLY BONDED TO THE EXTENSION SET DOWN STREAM AFTER MANUFACTURED. 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 BEFORE USE, IT WAS NOTICED THAT THE SEPTUM OF A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, WAS BROKEN. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE POSSIBLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7094618; MEDICAL DEVICE EXPIRATION DATE: 2022-04-30; DEVICE MANUFACTURE DATE: 2017-04-04. MEDICAL DEVICE LOT #: 7052677; MEDICAL DEVICE EXPIRATION DATE: 2022-02-28; DEVICE MANUFACTURE DATE: 2017-02-21. (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 BEFORE USE, IT WAS NOTICED THAT THE SEPTUM OF A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, WAS BROKEN. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355618 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, BNS Q-SYTE FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other