BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8921946 · Received August 22, 2019

    Report

    Report Number
    1710034-2019-00918
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 23, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE POTENTIAL LOT NUMBERS: THERE WERE MULTIPLE POTENTIAL LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9071776, MEDICAL DEVICE EXPIRATION DATE: 2/28/2022, DEVICE MANUFACTURE DATE: 3/12/2019. MEDICAL DEVICE LOT #: 9071777, MEDICAL DEVICE EXPIRATION DATE: 2/28/2022, DEVICE MANUFACTURE DATE: 3/12/209. MEDICAL DEVICE LOT #: 9029982, MEDICAL DEVICE EXPIRATION DATE: 12/31/2021, DEVICE MANUFACTURE DATE: 1/29/2019. INVESTIGATION SUMMARY: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOTS. CONCLUSION(S): INDETERMINATE: WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE NEEDLE DID NOT RETRACT AND A NEEDLE STICK INJURY OCCURRED TO THE NURSE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE NEEDLE DIDN'T RETRACT EVEN ACTIVATED SAFETY MECHANISM. NSI OCCURRED TO THE NURSE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE NEEDLE DID NOT RETRACT AND A NEEDLE STICK INJURY OCCURRED TO THE NURSE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE NEEDLE DIDN'T RETRACT EVEN ACTIVATED SAFETY MECHANISM. NSI OCCURRED TO THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717483 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other