BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC

    MDR report key: 9324681 · Received November 14, 2019

    Report

    Report Number
    1710034-2019-01229
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 27, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED 6 UNOPENED UNITS FROM LOT NUMBER 9193596. THE PACKAGING IS IN GOOD CONDITION. THE UNITS WERE NOT THE ¿ACTUAL UNIT¿ REPORTED IN THE COMPLAINT EVENT. A FUNCTIONAL TEST WAS PERFORMED WHERE THE UNITS ALL RETRACTED AS INTENDED. THE CATHETER TIPS WERE ALL FOUND ACCEPTABLE PER SPECIFICATIONS. BD WAS UNABLE TO CONFIRM OR IDENTIFY THE REPORTED ISSUE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. CONCLUSION(S): THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. ]

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD¿ 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC HAS BEEN FOUND DEFORMED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CATHETER WOULD NOT SEPARATE FROM THE NEEDLE AND THE CATHETER BROKE. PER EMAILS: I HAD AN INCIDENT TONIGHT WHEN PLACING AN IV, THE CATHETER WOULDN'T SEPARATE FROM THE NEEDLE. I REMOVED THE CATHETER AND THE NEEDLE AND THERE WAS A BREAK IN THE CATHETER ITSELF. ONE OF THE CT TECHS SAID SOMETHING SIMILAR HAPPENED TO HER THIS WEEK AS WELL INJURIES OR ADVERSE EVENT: NO ITEM: 382533 QUANTITY AFFECTED: 1 BX LOT NUMBER: 9193596 REPORTED ISSUE: PER CUSTOMER, HAD AN INCIDENT TONIGHT WHEN PLACING AN IV, THE CATHETER WOULDN'T SEPARATE FROM THE NEEDLE. I REMOVED THE CATHETER AND THE NEEDLE AND THERE WAS A BREAK IN THE CATHETER ITSELF.

    Additional Manufacturer Narrative · 1

    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 HAS BEEN REPORTED THAT ONE BD¿ 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC HAS BEEN FOUND DEFORMED DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CATHETER WOULD NOT SEPARATE FROM THE NEEDLE AND THE CATHETER BROKE. PER EMAILS: I HAD AN INCIDENT TONIGHT WHEN PLACING AN IV, THE CATHETER WOULDN'T SEPARATE FROM THE NEEDLE. I REMOVED THE CATHETER AND THE NEEDLE AND THERE WAS A BREAK IN THE CATHETER ITSELF. ONE OF THE CT TECHS SAID SOMETHING SIMILAR HAPPENED TO HER THIS WEEK AS WELL INJURIES OR ADVERSE EVENT: NO. ITEM: 382533. QUANTITY AFFECTED: 1 BX. LOT NUMBER: 9193596. REPORTED ISSUE: PER CUSTOMER, HAD AN INCIDENT TONIGHT WHEN PLACING AN IV, THE CATHETER WOULDN'T SEPARATE FROM THE NEEDLE. I REMOVED THE CATHETER AND THE NEEDLE AND THERE WAS A BREAK IN THE CATHETER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114214 BD¿ 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9193596 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other