BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC GLOBAL BL 22GA X 1.0IN

    MDR report key: 18284439 · Received December 7, 2023

    Report

    Report Number
    1710034-2023-01412
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 14, 2023
    Report Date
    March 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381023 AND LOT NUMBER 3240090. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    DEVICE PROBLEM CODE: A0510 - RETRACTION PROBLEM PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    MATERIAL :381023 UPDATED AND BATCH:3240090.

    Description of Event or Problem · 0

    MATERIAL#: 644696, BATCH#: UNKNOWN(3240090) PROVIDED AS UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT SAFETY BUTTON ON IV CATHETER DOES NOT IMMEDIATELY CAUSE RETRACTION OF NEEDLE INTO HANDLE WHEN DEPRESSED. THE NEEDLE WILL RETRACT WITH REPEATED ATTEMPTS AT DEPRESSING THE BUTTON. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SAFETY BUTTON ON IV CATHETER DOES NOT IMMEDIATELY CAUSE RETRACTION OF NEEDLE INTO HANDLE WHEN DEPRESSED. THE NEEDLE WILL RETRACT WITH REPEATED ATTEMPTS AT DEPRESSING THE BUTTON. ITEM#644696. LOT#3240090.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213011 INSYTE AUTOG BC GLOBAL BL 22GA X 1.0IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS ONB BECTON DICKINSON 3240090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown