BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD CATETER I.V. 20G X 1.16

    MDR report key: 10708083 · Received October 20, 2020

    Report

    Report Number
    9610048-2020-00145
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 21, 2020
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 0120897, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE DEVICE APPEARED TO BE USED AND THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. HOWEVER, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR TESTING WE WERE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ CATETERS I.V. 20G X 1.16¿ (1.1 X 30 MM) (LATIN AMERICA) HAD A NEEDLE THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING AN ARTERIAL PUNCTURE, WHILE REMOVING THE DEVICE, ITS PLASTIC PORTION (THAT STAYS INSIDE THE VESSEL) WAS PERFORATED BY THE MANDREL WITHOUT ACTIVATION OF THE SAFETY DEVICE. IT OCCURRED TWICE WITH SAME BATCHES. CUSTOMER FURTHER REPORTS ((B)(6), 01.OCT.2020): THE USE OF THE DEVICE WAS FOR AN ARTERIAL PUNCTURE FOR INVASIVE BLOOD PRESSURE READING. THE ONLY IMPACT TO PATIENT WAS THE NEEDING OF ONE MORE ARTERIAL PUNCTURE. THERE WAS NO VASCULAR COMPROMISING, NO MEDICAL INTERVENTION NEEDED, NOR INCREASE OF HOSPITALIZATION PERIOD EITHER."

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ CATETERS I.V. 20G X 1.16¿ (1.1 X 30 MM) (LATIN AMERICA) HAD A NEEDLE THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING AN ARTERIAL PUNCTURE, WHILE REMOVING THE DEVICE, ITS PLASTIC PORTION (THAT STAYS INSIDE THE VESSEL) WAS PERFORATED BY THE MANDREL WITHOUT ACTIVATION OF THE SAFETY DEVICE. IT OCCURRED TWICE WITH SAME BATCHES. CUSTOMER FURTHER REPORTS (B)(6) 2020: THE USE OF THE DEVICE WAS FOR AN ARTERIAL PUNCTURE FOR INVASIVE BLOOD PRESSURE READING. THE ONLY IMPACT TO PATIENT WAS THE NEEDING OF ONE MORE ARTERIAL PUNCTURE. THERE WAS NO VASCULAR COMPROMISING, NO MEDICAL INTERVENTION NEEDED, NOR INCREASE OF HOSPITALIZATION PERIOD EITHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173747 BD INSYTE AUTOGUARD CATETER I.V. 20G X 1.16 INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381834 0120897 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other