BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6883201 · Received September 21, 2017

    Report

    Report Number
    1710034-2017-00202
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 29, 2017
    Report Date
    October 10, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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: DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 7030912 ¿ THE LOT NUMBER WAS BUILT ON AFA LINE 2, FROM FEBRUARY 8, 2017 THRU FEBRUARY 12, 2017. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATIONS (B)(4), IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW 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 THE PEURA (END USER RISK ANALYSIS): YES. REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: (B)(4) VERSION I WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. QN / SAP DATABASE REVIEW: NO. REASON: A REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR A S2 - O3 LEVEL A INVESTIGATION PER (B)(4). VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED ONE USED IAG 22GA UNIT IN AN OPENED PACKAGE AND 18 UNUSED UNITS FROM THE LOT NUMBER 7030912. THE USED UNIT CONSISTED OF THE RETRACTED NEEDLE/SAFETY BARREL AND THE CATHETER/ADAPTER ASSEMBLIES. VISUAL/MICROSCOPIC EXAMINATION: USED UNIT - OBSERVED THE CHARACTERISTIC V SHAPE OF A SPEAR THRU IN THE CATHETER TUBING JUST ABOVE THE NOSE OF THE ADAPTER. UNUSED UNITS - OBSERVED NO SIGNS OF BENDS, CUTS, FRAYING, HOLES, KINKS, SPLITS, WRINKLES OR THE CHARACTERISTIC V-SHAPE OF A SPEAR THRU. WATER/AIR LEAK TEST: PERFORMED THE LEAK TEST BY USING A LAB SUPPLIED MALE SLIP LUER CONNECTED TO THE FEMALE CONNECTION SITE OF EACH CATHETER/ADAPTER: USED UNIT - LEAKAGE WAS OBSERVED AT THE AREA OF THE V SHAPE CUT UNUSED UNITS - NO LEAKAGE WAS OBSERVED IN ANY AREA OF THE CONNECTION SITE. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO, THE RETURNED USED UNIT PROVIDED FOR EVALUATION DISPLAYED THE CHARACTERISTIC V SHAPE OF A SPEAR THRU THAT LEAKED. CONCLUSION: CONCLUSIONS: THE DEFECT OF LEAKAGE AT CATHETER JUNCTION, AS STATED IN THE DESCRIPTION OF THE COMPLAINT WAS CONFIRMED. THE SOURCE OF THE LEAKAGE WAS FROM V SHAPE CUT, WHICH IS A CHARACTERISTIC OF DEFECT OF THE CANNULA SPEARING THE CATHETER WALL. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? YES; THE CUSTOMER EXPERIENCE WAS CONFIRMED BASED ON THE EVALUATION THAT WAS PERFORMED ON THE RETURNED USED UNIT. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? N/A; IT WAS NOT NECESSARY TO ACHIEVE REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE, AS THE DEFECT WAS CONFIRMED WITH THE RETURNED USED UNIT. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE: ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: THE CAUSE OF THE REPORTED DEFECT, NEEDLE THRU CATHETER AT THE BASE OF THE CATHETER, WAS POSSIBLY CAUSED BY MISALIGNMENT OF THE AUTOMATED EQUIPMENT USED IN THE MANUFACTURING PROCESS. THE UNIT WAS RETURNED IN AN OPENED PACKAGED, INDICATING A POSSIBILITY THAT THE DEFECT WAS CAUSED BY MANIPULATION OF THE DEVICE. RATIONALE: CORRECTIONS AND CAPA: CORRECTIVE ACTION PROJECT / CAPA (#): 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: DURING THE ASSEMBLY PROCESS THERE IS A 100 PERCENT AUTOMATED VISION SYSTEM INSPECTION FOR TIP SPEAR, BASE SPEAR AND LIE DISTANCE. DEFECT OF THIS TYPE FOUND DURING MANUFACTURING SHOULD BE DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 22 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS LEAKING DURING USE. NO REPORTED MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664220 22 G X 1 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7030912

    Patients

    Seq Age Sex Outcome Treatment
    1 Other