BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7613400 · Received June 19, 2018

    Report

    Report Number
    1710034-2018-00329
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    May 22, 2018
    Report Date
    June 26, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814542
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: REVIEW WAS PERFORMED ON THE LOT NUMBER: 5163676. THE LOT NUMBER WAS PACKAGED ON PACKAGING LINE 9 FROM JUNE 18, 2015 THRU JUNE 19, 2015 AND AUGUST 29, 2015 THRU AUGUST 29, 2015. THE REVIEW OF THE DHR¿S IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SET-UP AND IN PROCESS INSPECTIONS INCLUDED BUT WERE NOT LIMITED TO BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TEST. THESE WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. QN / SAP DATABASE REVIEW FINDINGS: THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT STATED IN THE COMPLAINT DESCRIPTION ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. 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. OBSERVATIONS: RECEIVED TWO UNUSED IAG 16GA UNIT IN PARTIALLY OPENED PACKAGE FROM THE LOT NUMBER; 5163676. VISUAL/MICROSCOPIC EXAMINATION: ONE PACKAGE WAS PARTIALLY OPENED AT THE BOTTOM OF THE BLISTER PACK. THE SEAL WAS NOT COMPROMISED IN THE OTHER PACKAGE. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. PER OBSERVATION OF THE PHOTOS PROVIDED THIS CHARACTERISTIC WAS MET. IN ADDITION, THE BOTTOM WEB IN THE PHOTOS REVEALED EVIDENCE OF ADEQUATE TRANSFER (ADHESIVE) FROM THE PAPER TOP WEB AT THE OPEN SEALS AND PARTIALLY OPEN SEALS OF THE PACKAGES (BLISTER PACKS). THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND PAPER TOP WEB ADHESIVE PRESENCE. BOTH VARIABLES WERE INCLUDED IN THE OBSERVATIONS CONCLUSIONS: THE DEFECT OF PACKAGE DAMAGED-DEFECTIVE-OTHER AS STATED IN EVENT DESCRIPTION WAS CONFIRMED WITH THE RETURNED UNITS. NO ANOMALIES WERE FOUND AND ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH WERE OBSERVED TO BE WITHIN SPECIFICATION. THE UNITS WERE ACCEPTABLE PER SPECIFICATION REQUIREMENTS. THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. CAPA 48637 WAS INITIATED TO ADDRESS THE ISSUE OF OPEN SEAL COMPLAINTS. TASKS ASSOCIATED WITH THE CAPA PLAN HAVE BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    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 SEAL ON A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER APPEARS DEGRADED, PACKETS OPENING SPONTANEOUSLY THEREFORE NO LONGER STERILE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455525 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5163676 30382903814542

    Patients

    Seq Age Sex Outcome Treatment
    1 Other