BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 11168122 · Received January 13, 2021

    Report

    Report Number
    3006948883-2021-00079
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    February 7, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 0140313 AND 9106857. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. CHECKED THE RETAINED SAMPLES FROM THE COMPLAINED BATCHES AND THERE IS NO ABNORMALITY . 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. ADDITIONALLY, VISUAL EVALUATION OF THE SUBMITTED PHOTOGRAPH AND THE RESULTING REVIEW OF THE MANUFACTURING PROCESS DETERMINED THAT THE IDENTITY OF THE MATERIAL IS SOLIDIFIED SILICONE. SILICONE IS A MATERIAL USED TO MANUFACTURE THIS DEVICE, AND IS APPLIED TO THE CATHETER AS A LUBRICANT FOR REDUCED RESISTANCE DURING INSERTION. EXCESS APPLICATION OF THE LUBRICANT IS CURRENTLY POSSIBLE DUE TO LIMITATIONS IN THE MANUFACTURING PROCESS. BD IS CURRENTLY INVESTIGATING POTENTIAL PROCESS CHANGES TO ELIMINATE THE OCCURRENCE OF SIMILAR EVENTS. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 214 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS VISIBLE SILLICON OIL PARTICLE IN THE NEEDLE THE PROBLEM OCCURRED IN THE PSYCHOGERIATRICS DEPARTMENT. THESE LOT# OCCURRED IN THE SAME DEPARTMENT.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9106857 , MEDICAL DEVICE EXPIRATION DATE: 2022-05-25 , DEVICE MANUFACTURE DATE: 2019-04-16. MEDICAL DEVICE LOT #: 0140313 , MEDICAL DEVICE EXPIRATION DATE: 2023-06-10 , DEVICE MANUFACTURE DATE: 2020-05-19 . A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 214 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS VISIBLE SILICON OIL PARTICLE IN THE NEEDLE THE PROBLEM OCCURRED IN THE PSYCHOGERIATRICS DEPARTMENT. THESE LOT# OCCURRED IN THE SAME DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62644 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1