BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER WITH PRN ADAPTER

    MDR report key: 12870274 · Received November 24, 2021

    Report

    Report Number
    3014704491-2021-00303
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 21, 2021
    Report Date
    December 5, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1020006. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA II¿ IV CATHETER WITH PRN ADAPTER THE UNIT PACKAGE WAS DAMAGED WHERE STERILITY OF THE PRODUCT WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER THE PATIENT HAD RECEIVED FLUID INFUSION, THE NURSE TOOK THE NEEDLE AND PREPARED TO REPLACE IT WITH AN INDWELLING NEEDLE. WHEN SHE TOOK IT OUT, SHE FOUND THE PACKAGING OF THE INDWELLING NEEDLE WAS DAMAGED, SHE REPLACED IT WITH ANOTHER INDWELLING NEEDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA II¿ IV CATHETER WITH PRN ADAPTER THE UNIT PACKAGE WAS DAMAGED WHERE STERILITY OF THE PRODUCT WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "AFTER THE PATIENT HAD RECEIVED FLUID INFUSION, THE NURSE TOOK THE NEEDLE AND PREPARED TO REPLACE IT WITH AN INDWELLING NEEDLE. WHEN SHE TOOK IT OUT, SHE FOUND THE PACKAGING OF THE INDWELLING NEEDLE WAS DAMAGED, SHE REPLACED IT WITH ANOTHER INDWELLING NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766092 BD INTIMA II¿ IV CATHETER WITH PRN ADAPTER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1020006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown