BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY

    MDR report key: 9617377 · Received January 22, 2020

    Report

    Report Number
    1710034-2020-00018
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    January 2, 2020
    Report Date
    February 21, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS FOR EVALUATION. BD RECEIVED 100 UNOPENED UNITS IN ONE BAG, 35 UNITS IN THEIR ORIGINAL BOX WITH AN IFU, AND A TOP WEBBING, BD SYRINGE, AND CATHETER ASSEMBLY IN A SMALL PLASTIC BAG. ALL UNITS FROM ITEM NUMBER 382523, LOT NUMBER 9212069. THROUGH THE EVALUATION, A SAMPLING OF 76 UNITS WERE USED FOR EVALUATION. THE UNITS WERE VISUALLY INSPECTED FOR DAMAGE OF THE SEPTUM AND ACTUATOR AS WELL AS DAMAGE OF THE ADAPTER AND CATHETER TUBING. NO DAMAGE WAS OBSERVED. A LEAK TEST WAS PERFORMED WHERE LEAKAGE WAS NOT OBSERVED. BD THEN PROCEEDED TO INSPECT THE ONE USED UNIT THAT WAS RETURNED FOR INVESTIGATION. THE USED UNIT DID NOT SHOW LEAKAGE. UPON MICROSCOPIC INVESTIGATION OF THE PART THERE WERE NO CRACKS OR HOLES IN THE CATHETER HUB OR TUBING OBSERVED. NO VISUAL DEFECTS OF THE SEPTUM/ACTUATOR WERE OBSERVED EITHER. THE DEFECT ¿CATHETER DEFECTIVE/DAMAGED¿ AS STATED IN THE REPORT WAS NOT CONFIRMED BASED ON EVALUATION OF THE RETURNED UNITS. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 124 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM) EXPERIENCED A HOLE IN THE CATHETER/LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382523, BATCH NO.: 9212069. PER EMAIL: INJURIES OR ADVERSE EVENT: NO. ITEM: 382523. QUANTITY AFFECTED: 124/EA. SERIAL/LOT NUMBER: 9212069. PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: HOLE IN BLUE HUB CAUSING A LEAK.

    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 124 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS BLOOD CONTROL TECHNOLOGY 22GA 1.00IN (0.9 X 25 MM) EXPERIENCED A HOLE IN THE CATHETER/LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382523, BATCH NO.: 9212069. PER EMAIL: INJURIES OR ADVERSE EVENT: NO. ITEM: 382523. QUANTITY AFFECTED: 124/EA. SERIAL/LOT NUMBER: (B)(4). PO #: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: HOLE IN BLUE HUB CAUSING A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82663 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 9212069 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other