BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7790628 · Received August 16, 2018

    Report

    Report Number
    9610847-2018-00270
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 19, 2018
    Report Date
    September 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. INVESTIGATION SUMMARY: PHOTOS WERE PROVIDED FOR OBSERVATION OF THIS INCIDENT. PHOTO (1) REVEALED A BLISTER PACK OF A 385100 Q-SYTE (TYVEK/BREATHER SIDE OF THE PACKAGE ONLY). PHOTO (2) REVEALED A BLISTER PACK (CLEAR FILM SIDE) WHICH WAS SEALED AND CONTAINED A Q-SYTE UNIT INTACT WITH THE BLUE DUSK CAP. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LUER FITTINGS INCOMPATIBLE WITH LOT #7272682 REGARDING ITEM #385100. DHR REVIEWS; WERE CONDUCTED ON THE Q-SYTE SUB-ASSEMBLY (P/N 8001498) LOT NUMBERS ASSOCIATED WITH THIS INCIDENT, WHICH DISCLOSED THE FOLLOWING: LOT 7240694; WAS BUILT ON QFA LINE 2 FROM 08SEPT2017 THROUGH 10SEPT2017 FOR THE QUANTITY OF (B)(4) EA. LOT 7258516; WAS BUILT ON QFA LINE 3 FROM 17SEPTT2017 THROUGH 19SEPT2017 FOR THE QUANTITY OF (B)(4) EA. LOT 7258518; WAS BUILT ON QFA LINE 3 FROM 19SEPT2017 THROUGH 21SEPT2017 FOR THE QUANTITY OF (B)(4) EA. LOT 7258519; WAS BUILT ON QFA LINE 4 FROM 19SEPT2017 THROUGH 21SEPT2017 FOR THE QUANTITY OF (B)(4) EA. 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. THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SAP (QN) REVIEW; WAS CONDUCTED ON THE Q-SYTE SUB-ASSEMBLY LOT NUMBERS ASSOCIATED WITH THIS INCIDENT. THERE WERE NOT REJECT ACTIVITY FINDINGS ASSOCIATED WITH THE ALLEGED DEFECT, THERE WERE NO QNS WERE INITIATED FOR THESE LOTS. 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. INDETERMINATE: AS THE PHOTOS PROVIDED FOR THIS INCIDENT DID NOT PROVIDED SUFFICIENT EVIDENCE; THE ALLEGED DEFECT WAS NOT IDENTIFIED OR CONFIRMED AND A ROOT CAUSE WAS NOT ESTABLISHED. WITHOUT A SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT STATED IN THE PIR. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. 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 WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH LUER FITTINGS INCOMPATIBLE/LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (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 WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH LUER FITTINGS INCOMPATIBLE/LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628964 BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7272682 30382903851004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other