BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE 24GA X 0.75IN

    MDR report key: 19193344 · Received April 26, 2024

    Report

    Report Number
    9610048-2024-00040
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 29, 2024
    Report Date
    September 18, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883110
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBERS 3062305 AND 3082670. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE DISPLAYING MATERIAL 38831114 WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURE SAMPLE SHOWED A PRODUCT WITH THE NEEDLE THROUGH THE CATHETER. IT IS POSSIBLE THAT THIS INCIDENT RESULTED DURING USE OF THE PRODUCT, WHEN THE 360-DEGREE ROTATION IS PERFORMED DURING THE PUNCTURE, THE CATHETER MAY HAVE BEEN PUSHED FORWARD, CAUSING IT TO TRANSFIX THE CATHETER DURING PUNCTURE AFTER RE-CANNULATING. IT IS ALSO POSSIBLE THAT THIS INCIDENT RESULTED FROM PRODUCT ASSEMBLY, DUE TO A FAILURE IN THE VISION SYSTEM WHICH ALLOWED A TRANSFIXED CATHETER TO BE RELEASED TO THE CUSTOMER. HOWEVER, IF THIS WERE TO HAVE OCCURRED, THE PRODUCT WOULD HAVE BEEN UNUSABLE UPON DELIVERY. A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED FOR THE DEFECT OF NEEDLE THROUGH CATHETER, TO FURTHER INVESTIGATE THIS ISSUE AND PREVENT ANY REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE 24GA X 0.75IN NEEDLE WENT THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM SPANISH TO ENGLISH: "WE HAVE RECEIVED NOTIFICATION OF ADVERSE INCIDENTS WITH THE BD INSYTE INTRAVENOUS CATHETER OF 24, 18, 20 GAUGE. IN PARTICULAR, WE HAVE BEEN INFORMED THAT THE IV CATHETER NO. 24 LOT 3062305 FV 02/2028 AT THE MOMENT OF UNCLOGGING THE CATHETER, THE CATHETER WAS CHECKED, AND THE MANDREL WAS OBSERVED TO BE PERFORATED BY THE NEEDLE. THE ICU SERVICE REPORTS AN INCREASE IN CASES OF MECHANICAL PHLEBITIS." ADDITIONAL INFORMATION RECEIVED APR 09 2024. WHAT IS THE QUANTITY AFFECTED? RT/ THE NOVELTY OF THE DEVICES HAS BEEN PRESENTED IN THE CATHETER NO. 18,22,20 AND 24 IN THE AREAS OF UCI EMERGENCY AND PEDIATRICS. HOWEVER, 2 CASES HAVE BEEN FORMALLY REPORTED WITH CATHETER NO. 24 AND 2 CASES WITH CATHETER NO. 18. WHAT IS THE LOT NUMBER OF THE PRODUCT? CATHETER 24: LOT: 3082670 EXPIRY DATE 30/03/2028 WAS THE REPORTED INCIDENT DETECTED BEFORE, DURING OR AFTER USE ON THE PATIENT? R/ BEFORE USE ON PATIENT AND IN USE ON PATIENT, GENERATING PHLEBITIS. HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? R/ PHLEBITIS HAS OCCURRED IN THE VEINS OF A MULTI-PUNCTURED PATIENT. - WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (IMAGING TESTS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) FOR THE MOMENT NO - HAS THERE BEEN EXPOSURE OF BLOOD/CHEMOTHERAPY TO MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF YES, INDICATE WHETHER THE EXPOSURE WAS FROM THE PATIENT OR THE PRACTITIONER AND WHAT MEASURES WERE TAKEN. (DETAIL) FOR THE TIME BEING NO - WHAT MEDICATION WAS BEING ADMINISTERED? R/ MEDICATION WAS NOT ADMINISTERED AS THERE WAS EVIDENCE OF DAMAGE AT THE TIME OF CHANNELING THE PATIENT. - IS THE SAMPLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? IF YES, REPORT THE QUANTITY. R/ THE CATHETERS HAVE BEEN DISCARDED. - COULD YOU PLEASE SEND PHOTO SAMPLES OF THE SPECIMEN? THE FOLLOWING PHOTOS ARE SENT AS EVIDENCE: - O DATE OF INCIDENT: MARCH 29, MARCH 30 AND APRIL 2 OF THE CURRENT YEAR:

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039045 BD INSYTE 24GA X 0.75IN PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3062305 00382903883110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown