BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 6963768 · Received October 19, 2017

    Report

    Report Number
    1710034-2017-00259
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    September 25, 2017
    Report Date
    September 29, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE # AND FAX REPORTER PHONE #: (B)(6). INVESTIGATION SUMMARY: THE CORRECTIVE ACTION STATEMENT IS APPROVED/AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY DESIGNATED COMPLAINT HANDLING UNIT. TYPE: MDR PHOTO. PART #: 381023. LOT #: 7060698. COMPLAINT: FOREIGN MATTER. EVENT DESCRIPTION: COMPLAINT FROM (B)(6). THE USER COMPLAINED THAT CATHETER FRAGMENT WAS FOUND STICKING ON THE TIP OF THE CATHETER. LOT ANALYSIS: DEVICE/BATCH HISTORY RECORD REVIEW: YES. REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). FINDINGS: AS THIS COMPLAINT WAS A MDR; DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBER: 7060698 ¿ THE LOT NUMBER WAS BUILT ON AFA LINE 10, FROM MARCH 3, 2017 THRU MARCH 8, 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. QN / SAP DATABASE REVIEW: NO. REASON: A REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR A S1 - O1 LEVEL A INVESTIGATION PER CPR ¿ 071. THE PEURA (END USER RISK ANALYSIS): YES. REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: (B)(4) REV 11 VERSION I WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: ALTHOUGH OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION, A PHOTO WAS SUBMITTED FOR REVIEWED. THE PHOTO PROVIDED SHOWN AN IAG/BC 22GA CATHETER/ADAPTER ASSEMBLY. THERE WAS A WHITE PARTICULATE ATTACHED AT THE TIP OF THE CATHETER TUBING AND ON THE PAPER WITHIN THE RED CIRCLE. NOTE: THE FM HAS THE SAME APPEARANCE AS RESIDUAL CATHETER MATERIAL THAT RESULTS FROM THE CATHETER TIPPING PROCESS; HOWEVER THE FM COULD NOT BE IDENTIFIED NOR COULD IT BE DETERMINED IF THE FM WAS MANUFACTURING RELATED; THEREFORE THIS INCIDENT IS INDETERMINATE. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO. THE PHOTO SUBMITTED FOR EVALUATION SHOWN FM PARTICULATE ATTACHED AT THE TIP OF THE CATHETER TUBING. INVESTIGATION CONCLUSION: CONCLUSIONS: THE DEFECT OF FOREIGN MATTER AS STATED IN THE SUBJECT OF THE PIR WAS CONFIRMED BASED ON THE REVIEW OF THE PHOTO SUPPLIED BY THE CUSTOMER. THERE WAS WHITE PARTICULATE WHICH ATTACHED TO THE CATHETER TUBING NEAR THE TIP THAT COULD NOT BE IDENTIFIED. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? YES; THE CUSTOMER EXPERIENCED WAS CONFIRMED BASED ON THE EVALUATION OF THE PHOTO SUBMITTED BY THE CUSTOMER. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO; IT WAS NOT NECESSARY TO ACHIEVE REPRODUCTION OF THE CUSTOMER¿S EXPERIENCE, AS THE DEFECT WAS CONFIRMED. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE DESCRIPTION: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: THE FM PARTICULATE OBSERVED ON THE TUBING OF THE UNIT IN THE PHOTO PROVIDED BY THE CUSTOMER COULD NOT BE IDENTIFIED; THEREFORE A DEFINITE ROOT CAUSE COULD NOT BE ESTABLISHED. RATIONALE: CORRECTIVE ACTION PROJECT / CAPA (#): CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A QUARTERLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES ARE 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 PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE TIP OF A 22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743504 22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7060698

    Patients

    Seq Age Sex Outcome Treatment
    1 Other