BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER 24 G X 0.56 IN.

    MDR report key: 7810649 · Received August 23, 2018

    Report

    Report Number
    1710034-2018-00583
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    August 3, 2018
    Report Date
    September 4, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815112
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES. INVESTIGATION SUMMARY: DHR-REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. RECEIVED 30 UNUSED IAG 24GA UNITS IN PARTIALLY OPENED PACKAGES. PACKAGES WERE PARTIALLY OPENED AT BOTH ENDS. ALL UNITS: 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 SEAL STRENGTH ARE SEAL TRANSFER/WIDTH AND TOP WEB GLUE. BOTH OF THESE VARIABLES WERE INCLUDED IN THE INVESTIGATION. WATER-LEAK TEST: THE WATER LEAK TEST WAS PERFORMED ON THE PACKAGES WHERE THE SEAL HAD NOT BEEN COMPROMISED. NO LEAKAGE WAS OBSERVED ON ANY OF THE AREAS OF THE PACKAGES TESTED. CONCLUSION(S): SUPPLIER OLIVER-TOLAS (OT) USES A STANDARD REINFORCED PAPER THAT IS COMMON TO MANY OTHER SUPPLIERS, BUT THE ADHESIVE TYPE AND APPLICATION IS SPECIFIC TO OT. 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 THAT BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETERS HAVE STERILE BREACH DUE TO A SLIGHTLY OPENED PACKAGES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7062566; MEDICAL DEVICE EXPIRATION DATE: 2020-02-29; DEVICE MANUFACTURE DATE: 2017-03-07. MEDICAL DEVICE LOT #: 7293637; MEDICAL DEVICE EXPIRATION DATE: 2020-09-30; DEVICE MANUFACTURE DATE: 2017-10-23. MEDICAL DEVICE LOT #: 6056539; MEDICAL DEVICE EXPIRATION DATE: 2019-02-28 DEVICE MANUFACTURE DATE: 2016-02-25. 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-N¿ AUTOGUARD¿ SHIELDED IV CATHETERS HAVE STERILE BREACH DUE TO A SLIGHTLY OPENED PACKAGES. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652748 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER 24 G X 0.56 IN. INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10. 30382903815112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other