BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNAP-LOCK MACORPORT INFUSE-A-KIT SYSTEM

    MDR report key: 127216 · Received October 20, 1997

    Report

    Report Number
    1220923-1997-00012
    Event Type
    Injury
    Date Received
    October 20, 1997
    Report Date
    September 23, 1997
    Manufacturer
    STRATO/INFUSAID INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/20/1997, THE MFR'S REP WAS INFORMED BY THE ONCOLOGIST NURSE THAT TO HER KNOWLEDGE, NO PROBLEMS HAVE BEEN ENCOUNTERED WITH REPLACEMENT DEVICE WHICH WAS REFERENCED (SECTION B.5. AS MEDWATCH REPORT #1220923-1997-00013) IN MEDWATCH REPORT #12209230-1997-00012 SUBMITTED TO THE FDA ON 10/20/1997, PRIOR TO THE RECEIPT OF THE ABOVE MENTIONED INFO. AS A RESULT OF THE INFO REC'D, THIS IS NOT A REPORTABLE EVENT AND MEDWATCH REPORT #1220923-1997-00013 WILL BE REASSIGNED TO A REPORTABLE INCIDENT. THEREFORE, PLEASE NOTE THE CORRECTION BELOW. SECTION H.11. CORRECTED DATA. MEDWATCH REPORT #1220923-1997-00012, SUBMITTED ON 10/20/1997, SECTION B.5. DESCRIBE EVENT OR PROBLEM, LINE SEVEN READ (REF MDR#'S 1220923-1997-00011, 00013, & 00014). SECTION B.5. SHOULD HAVE READ (REF MDR#'S 1220923-1997-00011, 00014).

    Description of Event or Problem · 1

    ON 09/23/1997, THE DISTRIBUTOR'S SALES REPRESENTATIVE CONTACTED THE MANUFACTURER'S (MFR'S) REPRESENTATIVE AND STATED THAT A CUSTOMER IN HER TERRITORY WAS HAVING A PROBLEM WITH THIS PRODUCT. THE DISTRIBUTOR'S SALES REPRESENTATIVE WAS INFORMED BY THE ONCOLOGIST'S NURSE THAT THEY HAVE HAD FOUR EVENTS CONCERNING THIS PRODUCT. THIS REPORT CONCERNS THE SECOND EVENT. THE ONCOLOGIST'S NURSE STATED THE DRUG BEING INSTILLED VIA THE DEVICE WAS LEUCOVORIN/5FU. UPON INFUSION, THE AREA AROUND THE DEVICE SITE BUBBLED UP AND AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE. THE DISTRIBUTOR'S SALES REPRESENTATIVE'S KNOWLEDGE, NO PROBLEMS HAVE BEEN ENCOUNTERED WITH THE REPLACEMENT DEVICE. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SNAP-LOCK MACORPORT INFUSE-A-KIT SYSTEM VASCULAR ACCESS DEVICE LJT STRATO/INFUSAID INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention