BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8299012 · Received February 1, 2019

    Report

    Report Number
    1710034-2019-00133
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 14, 2019
    Report Date
    March 1, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4317652, MEDICAL DEVICE EXPIRATION DATE: 11/30/2017, DEVICE MANUFACTURE DATE: 11/13/2014. MEDICAL DEVICE LOT #: 7244612, MEDICAL DEVICE EXPIRATION DATE: 8/31/2020, DEVICE MANUFACTURE DATE: 9/1/2017. MEDICAL DEVICE LOT #: 7220674, MEDICAL DEVICE EXPIRATION DATE: 7/31/2020, DEVICE MANUFACTURE DATE: 8/8/2017. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOTS. A TOTAL OF 14 UNITS WERE RECEIVED AS FOLLOWS: ONE UNIT WAS RECEIVED FROM EACH OF THE LOTS #: 4317652, 7059847, 7244612 AND 7220674. 3 UNITS FROM LOT # 7299860. 7 UNITS FROM LOT # 7089512. ALL CONTENTS WITHIN THE PACKAGES WERE INTACT. 4317652, 7059847, 7244612: THE UNITS RECEIVED WERE PARTIALLY OPEN AT ONE END OF THE PACKAGES. 7220674: THE UNIT RECEIVED WAS PARTIALLY OPEN AT BOTH ENDS OF THE PACKAGE. 7299860: ALL OF THE UNITS RECEIVED (3) WERE PARTIALLY OPEN AT ONE END OF THE PACKAGES 7089512: 4 OF THE UNITS RECEIVED WERE PARTIALLY OPEN AT BOTH ENDS OF THE PACKAGES. 3 OF THE UNITS RECEIVED WERE PARTIALLY OPEN AT ONE END OF THE PACKAGES. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL WIDTH WITH ADHESIVE TRANSFER FROM THE TOP WEB PAPER TO THE BOTTOM WEB FILM. THIS CHARACTERISTIC WAS MET. THE KEY VARIABLES THAT AFFECT THE PACKAGING SEAL ARE SEAL TRANSFER/WIDTH AND TOP WEB ADHESIVE PRESENCE. BOTH OF THESE VARIABLES WERE INCLUDED IN THE INVESTIGATION. BD SUPPLIER OLIVER-TOLAS USES A STANDARD REINFORCED PAPER THAT IS COMMON TO MANY OTHER SUPPLIERS, BUT THE ADHESIVE TYPE AND APPLICATION IS SPECIFIC TO OLIVER-TOLAS. THERE IS SUFFICIENT EVIDENCE TO DEMONSTRATE THE OLIVER-TOLAS MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. CAPA #: 48637 WAS OPENED TO INVESTIGATE THE PACKAGE SEAL INTEGRITY COMPLAINTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER PACKAGES WERE OPENED. THIS OCCURRED ON 14 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7299860. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2017-10-26. MEDICAL DEVICE LOT #: 7059847. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2017-03-06. MEDICAL DEVICE LOT #: 7089512. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2017-04-03. 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 INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER PACKAGES WERE OPENED. THIS OCCURRED ON 14 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91368 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other