BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ EXTENSION SET MICRO BORE

    MDR report key: 7938859 · Received October 5, 2018

    Report

    Report Number
    9610847-2018-00322
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 12, 2018
    Report Date
    December 13, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851028
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ALTHOUGH SAMPLES WERE NOT RECEIVED FOR THIS INVESTIGATION, 3 PHOTOS WERE PROVIDED FOR OBSERVATION OF THIS INCIDENT. THE UNIT IN THE PHOTOS CONSISTED OF A Q-SYTE BUILT TO AN EXTENSION LINE. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SEPTUM DAMAGED WITH LOT #7349662 REGARDING ITEM #385102. DHR REVIEWS; WERE CONDUCTED FOR THE SUB-ASSEMBLY LOT #S 7331615, 7340718 AND 7340719 (P/N (B)(4) WHICH DISCLOSED THE FOLLOWING: LOT 7331615; WAS BUILT ON QFA LINE 4, FROM 30NOV2017 THROUGH 02DEC2017 FOR THE QUANTITY OF 216,000EA. LOT 7340718; WAS BUILT ON QFA LINE 2, FROM 08DEC2017 THROUGH 10DEC2018 FOR THE QUANTITY OF 180,000EA. LOT 7340719; WAS PREVIOUSLY CONDUCTED FOR INVESTIGATION (PR 486246-573869 CR) WHICH DISCLOSED THAT THE LOT WAS BUILT ON QFA LINE 2, FROM 10DEC2017 THROUGH 12DEC2017 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 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. *ONE NON-RELATED TD (TD 2017-89 ¿SCALE SET-UP FOR CORRECT PART QUANTITY AS THERE ARE 2 TYPES OF SCALES) WAS IN AFFECT DURING THE BUILD THESE LOTS. SAP (QN) DATABASE REVIEW; WAS CONDUCTED ON THE Q-SYTE LOT NUMBERS WHICH DISCLOSED THE FOLLOWING. *THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT ASSOCIATED WITH THE Q-SYTE SUB-ASSEMBLY LOT NUMBERS FOR THIS INCIDENT, AS NO QNS WERE INITIATED. 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. PROBABLE ROOT CAUSE FOR THIS INCIDENT IS INDETERMINATE. ALTHOUGH CONFIRMATION OF SEPTUM PUSHED INTO ADAPTER (SEPTUM DAMAGED / DEFECTIVE) WAS CONFIRMED WITH THE PHOTOS PROVIDED, A DEFINITE SOURCE THAT CONTRIBUTED TO THIS DAMAGE COULD NOT BE ESTABLISHED. THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS AND/OR EXTRANEOUS FORCE. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT AS THE UNIT DEMONSTRATED TO HAVE EVIDENCE OF RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS ON RIM OF THE TOP BODY WHICH WERE INDICATIVE OF AN ADEQUATE BOND AT TIME OF MANUFACTURE. 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. 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 THE BD Q-SYTE¿ EXTENSION SET MICRO BORE SEPTUM WAS DAMAGED AND HAD COME UNGLUED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 THAT THE BD Q-SYTE¿ EXTENSION SET MICRO BORE SEPTUM WAS DAMAGED AND HAD COME UNGLUED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778341 BD Q-SYTE¿ EXTENSION SET MICRO BORE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7349662 30382903851028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other