BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 G X 1.25 IN. (1.1 MM X 31 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 6815877 · Received August 23, 2017

    Report

    Report Number
    1710034-2017-00145
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    August 2, 2017
    Report Date
    September 12, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7101910; MEDICAL DEVICE EXPIRATION DATE: 2020-03-31; DEVICE MANUFACTURE DATE: 2017-04-11; MEDICAL DEVICE LOT #: 7033667; MEDICAL DEVICE EXPIRATION DATE: 2020-01-31; DEVICE MANUFACTURE DATE: 2017-02-02; A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHRS ARE AVAILABLE FOR REVIEW AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE. FINDINGS: REVIEW WAS CONDUCTED FOR THIS MDR INCIDENT; REVIEW DISCLOSED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATIONS, IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO RELATED REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOTS THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. DHR REVIEW OF LOT NUMBER 7101910 REVEALED; THE LOT NUMBER WAS BUILT ON NFA LINE 1 FROM 11APR2017 THRU 15APR2017 IN THE QTY. 181,450EA. DHR REVIEW OF LOT NUMBER 7033667 REVEALED; THE LOT NUMBER WAS BUILT ON NFA LINE 1 FROM 03FEB2017 THRU 06FEB2017 IN THE QTY. 168,010EA. SAP (QN) DATABASE REVIEW: YES. REASON: THIS DATABASE TRACKS ANY ISSUE DURING PRODUCTION THAT WOULD AFFECT PRODUCT QUALITY. FINDINGS: SUBJECT CODES WERE AN S2 SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THIS MDR / LEVEL A INVESTIGATION; AS A RESULT THERE WERE NO RELATED REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECTS STATED IN THE PR ASSOCIATED TO THE LOTS NUMBER PROVIDED FOR THIS INCIDENT. END USER RISK ANALYSIS REVIEW: YES. REASON: THIS IS A MDR INCIDENT. FINDINGS: RM5769 V.12(K) AND RM5796 V.12(K) WERE ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE FAILURE MODE OF THREADING DIFFICULT AND CORRELATING NEEDLE DIFFICULT DISENGAGEMENT HAVE BEEN ASSESSED AND ARE ACCEPTABLE GIVEN THE LIMITED SEVERITY AND THE POTENTIAL NEED FOR A SECOND PIV INSERTION. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED TWO USED 20GA BD NEXIVA UNITS WITHIN OPEN PACKAGES: UNIT 1 IS FROM LOT 7101910 - THIS DEVICE WAS BUILT ACCORDING TO THE LOW DRAG DESIGN. UNIT 2 IS FROM LOT 7033667. EACH UNIT CONSISTED OF THE CATHETER/ADAPTER AND EXTENSION LINE ASSEMBLIES WITH THE FLOW PLUG INTACT AND THE PINCH CLAMP DISENGAGED. VISUAL/MICROSCOPIC EXAMINATION: UNITS 1 & 2: OBSERVED THERE WERE NO ANOMALIES OR DAMAGE THE CATHETER TUBING (I.E. CUT, WRINKLES, KINKS, ETC.). LIE DISTANCE AND CANNULA TIP ASSESSMENT WAS PERFORMED; COULD NOT BE OBTAINED DUE TO THE CONDITION IN WHICH THE UNIT WAS RECEIVED. CATHETER TIP GRADING WAS PERFORMED ON USED UNIT: THE CATHETER TIPS GRADED AT; UNIT 1 ¿4¿ AND UNIT 2 ¿5¿ (ACCEPTABLE PER SPECIFICATION). CATHETER DIP DEPTH WAS PERFORMED AND PENETRATION AND DRAG TESTING WAS PERFORMED (MM-92): COULD NOT BE OBTAINED AS ONLY USED UNITS WERE RECEIVED. NOTE THAT OBSERVATIONS AND TESTING FOR THE DEFECTS (1) THREADING DIFFICULT AND (2) NEEDLE DIFFICULT DISENGAGEMENT; COULD NOT BE CONDUCTED DUE TO THE CONDITION IN WHICH THE UNIT WAS RECEIVED. TEST DESCRIPTION: METHOD NO RESULTS: VISUAL/MICROSCOPIC N/A: SEE OBSERVATIONS AND TESTING. LIE DISTANCE PPS-169: SEE OBSERVATIONS AND TESTING. CANNULA TIP QUALITY ASSESSMENT MM-90 :SEE OBSERVATIONS AND TESTING. CATHETER TIP GRADING TIP-009 :SEE OBSERVATIONS AND TESTING. PEN AND DRAG TESTING QCNVA-05: SEE OBSERVATIONS AND TESTING. CATHETER DIP DEPTH QCNVA-05: SEE OBSERVATIONS AND TESTING. FUNCTIONAL (DISENGAGEMENT) N/A: SEE OBSERVATIONS AND TESTING. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES: THE UNIT REVEALED NO ANOMALIES OR DAMAGE. CONCLUSIONS: CONFIRMATION OF FAILURE OF (1) THREADING DIFFICULT AND (2) NEEDLE DIFFICULT DISENGAGEMENT, AS NOTED IN THE SUBJECT OF THE PR, WAS INCONCLUSIVE WITH THE USED UNITS PROVIDED FOR THIS INCIDENT. AS A RESULT OF THE EVALUATION AND TESTING PERFORMED, THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECTS THE CUSTOMER EXPERIENCED, PER THE PR. THE DEFECTS DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED REPRESENTATIVE UNIT. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO: (1 & 2) CONFIRMATION OF THE FAILURES (1) THREADING DIFFICULT AND (2) NEEDLE DIFFICULT DISENGAGEMENT WAS INCONCLUSIVE WITH THE USED UNITS PROVIDED FOR THIS INCIDENT. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO: REPRODUCTION OF THE FAILURES THE CUSTOMER EXPERIENCED WAS NOT ACHIEVED IN THE LABORATORY ENVIRONMENT AS TESTING COULD NOT BE CONDUCTED ON THE USED UNITS. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE: CORRECTIVE ACTION PROJECT / CAPA (#): A DEFINITE ROOT CAUSE WAS NOT ESTABLISHED. 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. OTHER ACTION TAKEN: PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND TO ENSURE ANY PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE...

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 22 G X 1.00 IN. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WOULD NOT ADVANCE DURING INSERTION AND WAS DRAGGING WHEN BEING RETRACTED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595209 20 G X 1.25 IN. (1.1 MM X 31 MM) BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other