BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7899553 · Received September 21, 2018

    Report

    Report Number
    1710034-2018-00656
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 31, 2018
    Report Date
    November 7, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818440
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE PHOTO SUBMITTED FOR REVIEW DISPLAYED NINE PACKAGES WITH EITHER THE TOP OR BOTTOM OF THE BLISTER PACK PARTIALLY OPENED. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE SEAL TRANSFER/WIDTH AND PAPER TOP WEB GLUE. PER THE PHOTO SUBMITTED, THESE VARIABLES COULD NOT BE EVALUATED. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE WITH LOT #7170703, 7257566, AND 7310924 REGARDING ITEM #381844. DHR REVIEWS WERE PERFORMED ON THE FOLLOWING LOT NUMBERS: 7257566; THE LOT NUMBER WAS BUILT ON AFA LINE 8 FROM 21SEPT17 THRU 23SEPT17. PACKAGED ON PACKAGING LINE 9 FROM 22SEPT17 THE 24SEPT17. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER 7310924; THE LOT NUMBER WAS BUILT ON AFA LINE 8 FROM 12NOV2017 THRU 18NOV2017. PACKAGED ON PACKAGING LINE 8 FROM 20NOV2017 THRU 22NOV2017. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. 7170703; THE LOT NUMBER WAS BUILT ON AFA LINE 8 FROM 26JUN2017 THRU 03JUL2017. PACKAGED ON PACKAGING LINE 8 FROM 29JUN2017 THRU 09JUL2017. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. 7289681; THE LOT NUMBER WAS BUILT ON AFA LINE 8 FROM 24OCT2017 THRU 27SEPT2017. PACKAGED ON PACKAGING LINE 8 AND 11 FROM 25OCT2017 THROUGH 28OCT2017. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. THERE WAS NOT SUFFICIENT EVIDENCE IN THE PHOTO TO DETERMINE IF ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH (SEAL TRANSFER AND PAPER TOP WEB GLUE) WERE MET. CONFIRMED THE UNITS, PER OBSERVATION OF THE PHOTO, WERE ACCEPTABLE. THE COMPLAINT TREND RESULTED IN INITIATION OF CAPA 48637. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXHIBITED STERILITY BREACH DUE TO PACKAGING RUPTURE. 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 #: 7257566, MEDICAL DEVICE EXPIRATION DATE: 2020-08-31, DEVICE MANUFACTURE DATE: 2017-09-14. MEDICAL DEVICE LOT #: 7310924, MEDICAL DEVICE EXPIRATION DATE: 2020-10-31, DEVICE MANUFACTURE DATE: 2017-11-07. MEDICAL DEVICE LOT #: 7170703, MEDICAL DEVICE EXPIRATION DATE: 2020-05-31, DEVICE MANUFACTURE DATE: 2017-06-19. MEDICAL DEVICE LOT #: 7289681, MEDICAL DEVICE EXPIRATION DATE: 2020-09-30, DEVICE MANUFACTURE DATE: 2017-10-16. (B)(6). 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¿ SHIELDED IV CATHETER EXHIBITED STERILITY BREACH DUE TO PACKAGING RUPTURE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737728 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 00382903818440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other