BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7157836 · Received January 2, 2018

    Report

    Report Number
    9610847-2017-00224
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    December 6, 2017
    Report Date
    February 19, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    00382903851003
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7116693, MEDICAL DEVICE EXPIRATION DATE: 04/30/2022, DEVICE MANUFACTURE DATE: 05/24/2017, MEDICAL DEVICE LOT #: 7145712, MEDICAL DEVICE EXPIRATION DATE: 04/30/2022, DEVICE MANUFACTURE DATE: 06/12/2017, MEDICAL DEVICE LOT #: 7086682, MEDICAL DEVICE EXPIRATION DATE: 02/28/2022, DEVICE MANUFACTURE DATE: 04/20/2017, (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: DHR REVIEW WAS CONDUCTED ON THE SUB-ASSEMBLY (Q-SYTE) LOT NUMBERS WHICH DISCLOSED THE FOLLOWING: 7116693: LOT 7094638; WAS BUILT ON QFA LINE 3, FROM 07APR2017 THRU 09APR2017. LOT 7094641; WAS BUILT ON QFA LINE 3, FROM 09APR2017 THRU 11APR2017. LOT 7088580; WAS BUILT ON QFA LINE 3, FROM 11APR2017 THRU 13APR2017. THIS LOT/DHR WERE PREVIOUSLY REVIEWED FOR PR 232782-245728 CR. 7145712: LOT 7100591; WAS BUILT ON QFA LINE 3, FROM 22APR2017 THRU 23APR2017. THIS LOT/DHR WAS PREVIOUSLY REVIEWED FOR PR 186587-222410 CR. LOT 7109868; WAS BUILT ON QFA LINE 3, FROM 24APR2017 THRU 25APR2017. LOT 7109869; WAS BUILT ON QFA LINE 3, FROM 26APR2017 THRU 27APR2017. 7086682: LOT 7048709; WAS BUILT ON QFA LINE 3, FROM 19FEB2017 THRU 21FEB2017. LOT 7052664; WAS BUILT ON QFA LINE 3, FROM 21FEB2017 THRU 21FEB2017. 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. 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. SAP (QN) DATABASE REVIEW FINDINGS: THIS INCIDENT WAS AN S3 SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THIS MDR-LEVEL B INVESTIGATION FOR THE Q-SYTE SUB-ASSEMBLY LOT NUMBERS. THE REVIEWS DISCLOSED NO RELATED REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECTS ASSOCIATED WITH THE SUB-ASSEMBLY LOT NUMBERS FOR THIS INCIDENT. OBSERVATIONS AND TESTING: RECEIVED ONE Q-SYTE UNIT WITHOUT PACKAGING. THE UNIT WAS RECEIVED IN 2 PORTIONS; TOP BODY AND BOTTOM BODY. VISUAL/MICROSCOPIC EXAMINATION: THE Q-SYTE WERE SEPARATED AT TOP BODY AND BOTTOM BODY (POLYCARBONATE). CONFIRMED THERE WAS THERE WAS EVIDENCE OF AN ADEQUATE WELD LINE BETWEEN THE TOP AND BOTTOM BODY (POLYCARBONATE); INDICATING A SUFFICIENT BOND AT TIME OF MANUFACTURE. OBSERVED THE RIM OF THE TOP BODY HAD CRACKLING. OBSERVED THE SLIT WAS CENTERED IN ITS CORRECT POSITION ON THE SEPTUM TOP DISK. THERE WAS A TEAR AT EACH END OF THE SLIT. THERE WERE NO TEARS TO THE COLUMN WALL OF THE UNIT. 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. NO FURTHER ANOMALIES OR DAMAGE WAS OBSERVED ON THE EXTERNAL AREAS OF THE RETURNED Q-SYTE UNIT. CONCLUSIONS: THE FINDINGS IN THIS INCIDENT WERE INDICATIVE THAT THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS FOR THE FAILURE. NO; THE Q-SYTE WAS OBSERVED TO HAVE A TEAR AT EACH END OF THE SLIT AT THE SEPTUM TOP AND BOTTOM DISK. ALTHOUGH THE Q-SYTE TOP BODY AND BOTTOM BODY WERE SEPARATED FROM EACH OTHER; THERE WAS EVIDENCE OF SUFFICIENT BOND (WELD) AT THE TIME OF MANUFACTURE. THE LOCATION WHERE THE TOP AND BOTTOM BODY WERE SEPARATED REVEALED EVIDENCE OF AN ADEQUATE WELD. THIS IS AN INDICATION THAT A BOND (WELD) WAS PROVIDED DURING THE MANUFACTURING PROCESS. A FAILURE MODE ASSOCIATED WITH THE RETURNED SAMPLE DID NOT INDICATE THAT MANUFACTURING PROCESS INTRODUCED THE DAMAGE OBSERVED. EXTERNAL FORCES MOST LIKELY CONTRIBUTED TO THE DAMAGE OBSERVED A DEFINITE SOURCE THAT CONTRIBUTED TO THE TEAR(S) AT THE END OF THE SLIT OF THE SEPTUM TOP/BOTTOM DISK WITH CRACKLING TO THE TOP BODY COULD NOT BE ESTABLISHED. THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS AND/OR EXTRANEOUS FORCE. IN-PROCESS INSPECTIONS ARE CONDUCTED DURING THE MANUFACTURING PROCESS TO IDENTIFY PROCESS CHANGES THAT COULD CONTRIBUTE DAMAGE AND/OR ADVERSELY AFFECT PRODUCT PERFORMANCE. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A MANUFACTURING RELATED ROOT CAUSE 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 · 1

    IT WAS REPORTED THAT THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEAKED DURING USE, AND WHEN TRYING TO REPLACE THE DEFECTIVE VALVE THE BD Q-SYTE BROKE IN HALF. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE LEUR ACCESS SPLIT-SEPTUM FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10. 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other