BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7906398 · Received September 25, 2018

    Report

    Report Number
    1710034-2018-00649
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    August 30, 2018
    Report Date
    October 25, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814672
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED THREE IAG 18GA UNITS FROM LOT NUMBER 6042643. PACKAGE WAS PARTIALLY OPENED, BUT THIS IS THE BASIS OF THE COMPLAINT. DHR REVIEW WAS PERFORMED ON THE LOT NUMBER 6042643: THE LOT NUMBER WAS BUILT ON AFA LINE 6 FROM (B)(6) 2016 THRU (B)(6) 2016. PACKAGED ON PACKAGING LINE 11 FROM (B)(6) 2016 THRU (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 TWO NON-RELATED QNS WERE INITIATED DURING THE BUILD OF THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED. 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. THE DEFECT STATED IN THE DESCRIPTION OF THE COMPLAINT WAS CONFIRMED WITH THE RETURNED UNIT THAT WAS PARTIALLY OPEN AT BOTH ENDS 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. (B)(4) WAS OPENED TO INVESTIGATE THE PACKAGE SEAL INTEGRITY COMPLAINTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGING FOR A BD INSYTE AUTOGUARD SHIELDED IV CATHETER HAD ADHESIVE THAT FAILED TO KEEP THE PACKAGING CLOSED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 THE PACKAGING FOR A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER HAD ADHESIVE THAT FAILED TO KEEP THE PACKAGING CLOSED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749489 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6042643 30382903814672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other