BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8039241 · Received November 5, 2018

    Report

    Report Number
    1710034-2018-00803
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 10, 2018
    Report Date
    December 18, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    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: DHR: 7102795. THE PRODUCT WAS BUILT ON AFA LINE 6 FROM (B)(6)2017 THROUGH (B)(6)2017. PACKAGING LINE 9 ON (B)(6)2017 FOR THE AMOUNT OF 157,010EA. A NON-RELATED TD ( 2017-37 ¿ FOR SCHEDULE UPDATED ON PM¿S) WAS IN PLACE DURING PRODUCTION. NO QNS WERE INITIATED DURING PRODUCTION. ALL CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. 7262766. THE PRODUCT WAS BUILT ON AFA LINE 6 FROM (B)(6) 2017 THROUGH (B)(6)2017. PACKAGED ON PKG LINE 8 ON (B)(6)2017 THROUGH (B)(6)2017. A NON-RELATED TD (2017-60 FOR FLUSH SCHEDULE UPDATE) WAS IN PLACE DURING PRODUCTION. NO QNS WERE INITIATED DURING PRODUCTION. ALL CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. RECEIVED A TOTAL OF 3 IAG UNITS OF WHICH 2 WERE FROM LOT 7102795 AND 1 FROM LOT NUMBER 7262766, ALL COMPONENTS WITHIN WERE PRESENT AND INTACT. ALL 3 OF THE UNITS RECEIVED WERE PARTIALLY OPEN AT ONE END. 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. CONCLUSION(S): SUPPLIER ¿ DEFECTIVE MATERIAL. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7102795. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2017-04-12. MEDICAL DEVICE LOT #: 7262766. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2017-09-19. (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 WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876902 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other