BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS

    MDR report key: 15955962 · Received December 10, 2022

    Report

    Report Number
    1710034-2022-00786
    Event Type
    Malfunction
    Date Received
    December 10, 2022
    Date of Event
    November 18, 2022
    Report Date
    January 23, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. THIS WAS A PACKAGING ISSUE WHERE STERILITY OF THE PRODUCT WAS NOT COMPROMISED, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THIS IS NOT A LOT#: 2244512 MANUFACTURED FOR THE REPORTED CATALOG#.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS HAD BLACK PARTICLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNFORTUNATELY, A BATCH OF CATHETERS FAILED OUR INCOMING TESTING (THIS TESTING IS VISUAL AND INVOLVES SAMPLING 13 CATHETERS AND REVIEWING FOR PRINT ACCURACY AND OBVIOUS DEFECTS). IN THIS CASE 1 OF THE CATHETERS EXHIBITED A BLACK PARTICLE SIMILAR TO PREVIOUSLY REPORTED SCARS IN 2020 BATCH OF BD INSYTE AUTOGUARD 20GA CATHETER FAILED INCOMING QC TESTING SOP IQP-058 "PROCEDURE FOR SAMPLING, ON 17 NOV 22, 13 SAMPLES WERE CHECKED BY QC ANALYST CHUN. A BLACK PARTICLE WAS NOTED ON ONE OF THE SAMPLES. 12 OTHER SAMPLES CHECK WERE FREE FROM DIRT AND MET INCOMING SPECIFICATION. AS 1 OF THE CATHETERS HAD VISIBLE DIRT, IT DID NOT MEET SPECIFICATION AND IS NOT ACCEPTABLE. IQP-058 STATED THAT THE AQL IS FAIL ON 1 DEFECT. BATCH WAS REJECTED BY QC.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS HAD BLACK PARTICLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UNFORTUNATELY, A BATCH OF CATHETERS FAILED OUR INCOMING TESTING (THIS TESTING IS VISUAL AND INVOLVES SAMPLING 13 CATHETERS AND REVIEWING FOR PRINT ACCURACY AND OBVIOUS DEFECTS). IN THIS CASE 1 OF THE CATHETERS EXHIBITED A BLACK PARTICLE SIMILAR TO PREVIOUSLY REPORTED SCARS IN 2020 BATCH OF BD INSYTE AUTOGUARD 20GA CATHETER FAILED INCOMING QC TESTING SOP IQP-058 "PROCEDURE FOR SAMPLING, ON (B)(6) 2022, 13 SAMPLES WERE CHECKED BY QC ANALYST CHUN. A BLACK PARTICLE WAS NOTED ON ONE OF THE SAMPLES. 12 OTHER SAMPLES CHECK WERE FREE FROM DIRT AND MET INCOMING SPECIFICATION. AS 1 OF THE CATHETERS HAD VISIBLE DIRT, IT DID NOT MEET SPECIFICATION AND IS NOT ACCEPTABLE. IQP-058 STATED THAT THE AQL IS FAIL ON 1 DEFECT. BATCH WAS REJECTED BY QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625776 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2244512

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown