BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 8190204 · Received December 21, 2018

    Report

    Report Number
    1710034-2018-00919
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 3, 2018
    Report Date
    January 17, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER HAD STERILITY BREACH. THIS MALFUNCTION AFFECTED 5 DEVICES. INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBER 6130990; THE LOT NUMBER WAS MANUFACTURE ON AFA LINE 4 FROM (B)(6) 2016. PACKAGING LINE 9 FROM (B)(6) 2016. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. RECEIVED FIVE IAG 24GA UNITS FROM LOT NUMBER 6130990. PACKAGE WAS PARTIALLY OPENED, BUT THIS IS THE BASIS OF THE COMPLAINT. VISUAL/MICROSCOPIC EVALUATION: 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 VARIABLES WERE INCLUDED IN THE INVESTIGATION. THE DEFECT STATED IN THE DESCRIPTION OF THE COMPLAINT WAS CONFIRMED WITH THE RETURNED UNITS THAT WAS PARTIALLY OPEN AT THE TOP AND BOTTOM OF THE BLISTER PACK. EVEN THOUGH THE PACKAGES WERE RECEIVED PARTIALLY OPENED, ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL WERE OBSERVED TO BE WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. BD SUPPLIER OLIVER-TOLAS (OT) 29LP 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 OT MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. DUE TO CONTINUOUS ISSUES WITH OT, BD IS MOVING TO AN ALTERNATE SUPPLIER FOR THE TOP WEB MATERIAL. 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 SHIELDED IV CATHETER HAD STERILITY BREACH. THIS MALFUNCTION AFFECTED 5 DEVICES.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER HAD STERILITY BREACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029043 BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6130990 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other