BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 13261535 · Received January 14, 2022

    Report

    Report Number
    1710034-2022-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 21, 2021
    Report Date
    February 7, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL?: YES. D9: RETURNED TO MANUFACTURER ON: 1/19/2022. H6: INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED FOUR HUNDRED AND SIX UNOPENED UNITS FROM LOT NUMBER 1133071. IN ADDITION, FIVE PHOTOS WERE RECEIVED FOR INVESTIGATION. INVESTIGATION FOUND THAT THE TOP WEB WAS MISALIGNED RESULTING IN NO BLUE DASHED LINE ON SOME OF THE DEVICES FROM POCKET ONE. THIS WAS VERIFIED BY THE OBSERVED TENTH LINE VISIBLE AT THE BOTTOM OF POCKET TEN. THE BLUE DASHED LINE WAS ALSO OBSERVED TO BE ON THE OPPOSITE SIDE OF THE PRINT. THE REPORTED ISSUE WAS CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. ALL THE UNITS FROM PACKAGING POCKET ONE WERE FOUND TO BE WITHOUT THE BLUE DASHED LINE AND HAD EXCESS MATERIAL ON THE TOP OF THE PACKAGE (TOTAL OF FORTY-FIVE UNITS). IN CONJUNCTION WITH THIS ALL UNITS FROM PACKAGING POCKET TEN WERE FOUND TO HAVE SOME EXCESS PACKAGING MATERIAL ON THE BOTTOM WITH A SMALL AMOUNT OF THE BLUE DASHED LINE (TOTAL OF FORTY UNITS). DURING THE INSPECTION INTO THE MISSING BLUE PRINT IT WAS IDENTIFIED THAT ALL UNITS WITH THE DASHED BLUE LINE SHOULD HAVE THE LINE UNDER THE PACKAGING PRINT AND NOT ON TOP AS OBSERVED IN THE RETURNED UNITS. THE EXTRA BLUE PRINT ON POCKET TEN BOTTOM, THE INCORRECT PLACEMENT OF THE BLUE PRINT ON UNITS TWO THROUGH TEN, AND THE LACK OF THE BLUE PRINT ON POCKET ONE INDICATES THAT THE TOP WEB WAS MOST LIKELY MISALIGNED DURING THE PACKAGING PROCESS. IT IS THE OPERATOR¿S RESPONSIBILITY TO ENSURE THAT A NEW ROLE IS FED CORRECTLY INTO THE MACHINE AND POCKETS ONE THROUGH TEN ARE PRINTED CORRECTLY. ADDITIONALLY PERIODIC INSPECTIONS ARE PERFORMED TO ENSURE THE SEAL AND PACKAGING ARE WITHIN SPECIFICATION PER THE SAMPLING PLAN. TO ENSURE THE PACKAGES ARE WITHIN SPECIFICATION, THE PACKAGES WERE THEN INSPECTED FOR SEAL WIDTH. THE SEAL WIDTH WAS CONFIRMED TO BE WITHIN SPECIFICATION. IN ADDITION, TWO UNITS WERE FOUND TO CONTAIN A FOREIGN MATTER WITHIN THE SEALED PACKAGE WHICH CAN BE ATTRIBUTED TO THE MANUFACTURING OR PACKAGING PROCESS. THE FOREIGN MATTER WAS UNABLE TO BE IDENTIFIED WITH CERTAINTY HOWEVER NO FOREIGN MATTER WAS OBSERVED IN THE FLUID PATH.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN A LABEL HAD NO INFORMATION ON IT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A PACKAGE PRINT DEFECT. PRODUCT INFORMATION IS USUALLY LIGHT BLUE-PRINTED ON THE PACKAGE; HOWEVER, THERE WAS NO PRINT ON SOME PACKAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA 1.00IN A LABEL HAD NO INFORMATION ON IT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT A PACKAGE PRINT DEFECT. PRODUCT INFORMATION IS USUALLY LIGHT BLUE-PRINTED ON THE PACKAGE; HOWEVER, THERE WAS NO PRINT ON SOME PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961426 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1133071

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown