BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8124147 · Received December 3, 2018

    Report

    Report Number
    1710034-2018-00857
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 9, 2018
    Report Date
    January 7, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH FOREIGN MATTER ON TWO UNITS. INVESTIGATION SUMMARY: RECEIVED TWO UNUSED IAG 24GA UNITS IN SEALED PACKAGES FROM CATALOG NUMBER 381812, LOT NUMBER 8071624. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER WITH LOT #8071624 REGARDING ITEM #381812. DHR REVIEW WAS PERFORMED. THE LOT NUMBER WAS BUILT ON AFA LINE 4 FROM 18MAR2018 THRU 23MAR2018. PACKAGED ON PACKAGING LINE 9 FROM (PALLETS 1-14) 21MAR2018 THRU24MAR2018 AND (PALLET 19) ON 01MAY2018. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED ONE NON-RELATED QN WAS INITIATED DURING THE BUILD OF THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. THE PEURA (END USER RISK ANALYSIS) RM5835 REV 14 VERSION L WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE INVESTIGATION CONCLUSION: OBSERVED BLACK SPECKS EMBEDDED INTO THE NEEDLE COVER OF BOTH UNITS. BASED ON THE EVALUATION OF THE SUBMITTED PHOTOS DISPLAYED THE SAME DEFECT AS THE RETURNED DISPLAYED. THE DEFECT FOREIGN MATTER WAS CONFIRMED. ROOT CAUSE DESCRIPTION: THE BLACK SPECKS THAT WAS OBSERVED WERE CREATED AS PART OF THE NORMAL MOLDING PROCESS WITH THIS MATERIAL. THE BLACK SPECKS WERE BURNT PARTICULATE RESIN; WHICH RESULT FROM MATERIAL HAVING A LONGER RESIDENCE TIME IN THE MOLD. THAT WOULD NOT AFFECT FIT, FORM OR FUNCTION OF THE PRODUCT. RATIONALE: A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED MONTHLY. 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 THAT BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH FOREIGN MATTER ON TWO UNITS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962925 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8071624 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other