BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7533983 · Received May 22, 2018

    Report

    Report Number
    9610847-2018-00144
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 30, 2018
    Report Date
    August 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 · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW: MDR: REVIEW WAS CONDUCTED ON THE SUB-ASSEMBLY (Q-SYTE) LOT NUMBER WHICH DISCLOSED THE FOLLOWING: LOT # 7209836: SUB-ASSEMBLY LOT 7180763; WAS BUILT ON QFA LINE3, FROM 11JUL2017 THRU 13JUL2017 FOR THE QUANTITY OF 180,000EA. SUB-ASSEMBLY LOT 7191939; WAS BUILT ON QFA LINE3, FROM 15JUL2017 THRU 17JUL2017 FOR THE QUANTITY OF 180,000EA. SUB-ASSEMBLY LOT 7191944; WAS BUILT ON QFA LINE2, FROM 14JUL2017 THRU 116JUL2017 FOR THE QUANTITY OF 180,000EA. 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, LEAK AND FOR FOREIGN-NON-FOREIGN 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 THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SAP (QN) DATABASE REVIEW: YES. REASON: THIS DATABASE TRACKS ANY ISSUE DURING PRODUCTION THAT WOULD AFFECT PRODUCT QUALITY. FINDINGS: THIS INCIDENT WAS AN S21SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THIS MDR-LEVEL A INVESTIGATION FOR THE Q-SYTE SUB-ASSEMBLY LOT NUMBERS. THE REVIEWS DISCLOSED NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT ASSOCIATED WITH THE SUB-ASSEMBLY LOT NUMBERS FOR THIS INCIDENT. ANALYSIS OF PEURA AND/OR FMEA CONDUCTED BY QE: Q-SYTE: THE PEURA (END USER RISK ANALYSIS) RM5699 V.5 (D) WAS REVIEWED AND IT WAS CONFIRMED THAT THE FAILURE MODES ARE IDENTIFIED. IN ADDITION, THE RISK IS ACCEPTABLE GIVEN A LOW OCCURRENCE. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED ONE Q-SYTE UNIT ACCOMPANIED BY AN OPENED PACKAGE FROM LOT 7209836. THE UNIT HAD THE BLUE DUST CAP PRESENT AND INTACT. THERE WAS A FOREIGN SUBSTANCE ON THE Q-SYTE UNIT AND SLIGHT AMOUNTS OF FM ON THE PACKAGING. THIS INCIDENT WAS PREVIOUSLY INVESTIGATED WITH A PHOTO WHICH REVEALED SIMILAR FINDINGS TO THAT OF THE UNIT PROVIDED. VISUAL/MICROSCOPIC: OBSERVED THAT THERE WERE SOME BLACK SPECS (SOIL AND FIBERS) ON THE SEPTUM TOP DISK AND ON THE TOP AND BOTTOM BODY OF THE Q-SYTE. OBSERVED THAT THE BLACK FOREIGN MATTER ON THE BLUE DUST CAP WAS SOIL AND BLACK FIBER PARTICULATES AND WAS THROUGHOUT THE LENGTH OF THE DUST CAP AND WITHIN THE LOWER END OF THE DUST CAP. NOTED BY THE LOCATION OF THE FOREIGN MATTER THAT IT WAS EVIDENT THAT THE FAILURE WAS MANUFACTURING RELATED. REMOVAL OF FOREIGN MATTER: THE FOREIGN MATTER ON THE BODY OF THE Q-SYTE AND BLUE DUST CAP WAS EASILY REMOVABLE. USED A SWAB STICK AND PURIFIED WATER; THE FOREIGN MATTER WIPED OFF. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO: THE UNIT PROVIDED FOR THIS INCIDENT REVEALED A Q-SYTE OUT OF PACKAGING THAT HAD A SLIGHT BLACK SPECS ON THE PACKAGE AND SOIL AND BLACK FIBER PARTICULATES THROUGHOUT THE LENGTH AND WITHIN THE DUST CAP. INVESTIGATION CONCLUSION: ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: MANUFACTURING ALTHOUGH THE FM (SOIL AND FIBERS) WAS CONFIRMED TO BE THROUGHOUT THE LENGTH AND WITHIN THE BLUE DUST CAP AND WAS INTRODUCED DURING THE MANUFACTURING PROCESS PRIOR TO PACKAGING; THE ACTUAL ORIGIN WAS NOT ESTABLISHED.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER (DESCRIBED AS ¿DUST PARTICLES ARE SUSPECTED AS THE CAUSE OF THE CONTAMINATION¿) WAS FOUND ON A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER (DESCRIBED AS ¿DUST PARTICLES ARE SUSPECTED AS THE CAUSE OF THE CONTAMINATION¿) WAS FOUND ON A BD Q-SYTE LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). 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 FOREIGN MATTER (DESCRIBED AS ¿DUST PARTICLES ARE SUSPECTED AS THE CAUSE OF THE CONTAMINATION¿) WAS FOUND ON 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
    377486 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE Q-SYTE FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7209836 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other