BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9489360 · Received December 18, 2019

    Report

    Report Number
    3006948883-2019-01104
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    January 5, 2019
    Report Date
    January 2, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233343. OUR RECORDS SHOW THAT THIS IS THE SECOND INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ADDITIONALLY, ALTHOUGH A SAMPLE WAS NOT RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION, ACCORDING TO PREVIOUS INVESTIGATIONS, THROUGH A VARIANCE IN THE AUTOLINE'S SWAGE PRESSURE IT IS POSSIBLE FOR THE MACHINE TO APPLY EXCESS FORCE TO THE DEVICE DURING ASSEMBLY, ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE. CURRENTLY, WE ARE CONDUCTING A LONG TERM STUDY (CAPA 642738) TO DETERMINE THE ROOT CAUSE FOR THIS EVENT, BUT WE ARE ADDRESSING THE ISSUE THROUGH THE IMPLEMENTATION OF MANUAL INSPECTIONS FOR CRACKS IN THE ADAPTER HEAD, AND WE ARE FURTHER OPTIMIZING OUR SWAGING PROCESS BY REDUCING DEPTH REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, ACCORDING TO THE STANDARD OF INTRAVENOUS THERAPY, WHEN BD CLOSED VENOUS INDWELLING NEEDLE WAS USED FOR THE PATIENT, THERE WERE CRACKS IN THE TRANSPARENT TEE OF THE INDWELLING NEEDLE, RESULTING IN THE OUTFLOW OF BLOOD, RESULTING IN THE PUNCTURE FAILURE. THEREFORE, THE INDWELLING NEEDLE SHOULD BE PULLED OUT AND RE-PUNCTURED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, ACCORDING TO THE STANDARD OF INTRAVENOUS THERAPY, WHEN BD CLOSED VENOUS INDWELLING NEEDLE WAS USED FOR THE PATIENT, THERE WERE CRACKS IN THE TRANSPARENT TEE OF THE INDWELLING NEEDLE, RESULTING IN THE OUTFLOW OF BLOOD, RESULTING IN THE PUNCTURE FAILURE. THEREFORE, THE INDWELLING NEEDLE SHOULD BE PULLED OUT AND RE- PUNCTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286650 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER FOZ BD (SUZHOU) 8233343

    Patients

    Seq Age Sex Outcome Treatment
    1 Other