BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 20065611 · Received August 26, 2024

    Report

    Report Number
    9610048-2024-00136
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 1, 2024
    Report Date
    November 8, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883110
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 3296534. 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. AS THERE WERE NO PICTURE SAMPLES OR PHYSICAL SAMPLES AVAILABLE FOR THE MATERIAL CAPTURED IN THIS RECORD, A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED. PLEASE NOTE THAT THIS RECORD CAPTURES MATERIAL 38831114 (INSYTE 24G) AND THE ORIGINAL PICTURES PROVIDED SHOW MATERIAL 38831214 (INSYTE 22G), WHICH WAS CAPTURED IN BD (B)(4). BASED ON THE INVESTIGATION RESULTS FOR THIS RECORD, WE WERE UNABLE TO DETERMINE EXACT CAUSES FOR THE REPORTED INCIDENTS. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    CLARIFICATION: "DOES NOT HAVE A SAFETY SYSTEM & IT DOES NOT HAVE A GUIDE TO ADVANCE CATHETER" MDR CAPTURE IS NOT REQUIRED AS THIS FEATURE IS NOT PART OF THE DEVICE DESIGN. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON SEP 02,2024 1. DID THE CANNULA (STEEL NEEDLE) BEND AND BREAK? THE NEEDLE BENDS WHEN TRYING TO CHANNEL THE PATIENT. 2. IS THERE A PROBLEM WITH THE CATHETER (SILICONE)? 3. WAS THE CATHETER NEEDLE DAMAGED? WHEN THE HEALTHCARE STAFF TRIES TO POSITION THE CATHETER, WHEN HANDLING THE NEEDLE, IT BREAKS. 3. IT HAS BEEN REPORTED THAT "IT DOES NOT HAVE A SECURITY SYSTEM", COULD YOU EXPLAIN WHAT THE PROBLEM IS? SINCE THIS PRODUCT DOES NOT HAVE A SAFETY SYSTEM IN ITS DESIGN. IT IS CLEAR THAT THE PRODUCT DOES NOT HAVE THIS SYSTEM, AND IN FACT IN THE ANALYSES CARRIED OUT IT IS REFERRED TO THAT WHAT WAS REPORTED IS MORE ASSOCIATED WITH THE DESIGN OF THE CATHETER AND NOT WITH THE QUALITY OF THE PRODUCT AS SUCH; BUT IT REPRESENTS A PROBLEM, SINCE THE CATHETER, NOT HAVING A SAFETY SYSTEM, IMPLIES RISKS IN ITS HANDLING, AS REPORTED BY THE HEALTHCARE PERSONNEL. 4. COULD YOU EXPLAIN IN MORE DETAIL THE PROBLEM WITH CATHETER ADVANCEMENT? TO EXPLAIN, I USE THE REFERENCE IMAGE, TO DETAIL WHAT WAS REPORTED BY THE CARE STAFF, THE CANOPY IS NOT SECURELY ATTACHED TO THE NEEDLE PORT, MAKING IT DIFFICULT TO HANDLE IT IS DIFFICULT TO POSITION THE NEEDLE FOR THE PUNCTURE SINCE IT DOES NOT HAVE AN INDICATOR FOR THE BEVEL OF THE NEEDLE, WHICH CAUSES THAT: CAUSES SKIN BARRIER AND HINDERS VENOUS ACCESS. IT DOES NOT ALLOW A GOOD PLACEMENT IN THE VEIN, WHICH WHEN CHANNELED GENERATES RESISTANCE IN THE ACCESS AND HAS TO BE PUNCTURED SEVERAL TIMES UNTIL THE CATHETER IS POSITIONED. 5. COULD YOU CONFIRM IF THERE WERE ANY REPERCUSSIONS ON THE HEALTH OF THE PATIENTS? DETAIL. SEVERAL CASES OF PHLEBITIS ASSOCIATED WITH CATHETER USE HAVE BEEN REPORTED ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER SEP 10,2024. 1. THE PICTURE PROVIDED IS INSYTE 22GA (BLUE ADAPTER), HOWEVER THE MATERIAL #38831114 INSYTE 24GA (YELLOW). CAN YOU SHARE INSYTE 24GA WALLPAPERS? I DON'T HAVE EVIDENCE FOR THIS CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE NEEDLE BREAKS THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: REPORT NO. (B)(4) WAS RECEIVED FROM THE HEAD OF THE ADULT IMPATIENT WHERE SHE REFERS THAT WHEN USING A NEW MEDICAL DEVICE (INTRACATH # 24) BD INSYTE BRAND, THIS DURING THE PUNCTURE OF THE PATIENT GENERATES TRAUMA IN THE VEIN SINCE THE CANNULA BENDS AND BREAKS WITH THE MANDREL, CAUSING THE NEED TO MULTI-PUNCTURE THE PATIENT, ADDITIONALLY WHEN REMOVING THE MANDREL IT DOES NOT HAVE A SECURITY SET CAUSING BIOLOGICAL RISK FOR HEALTH PERSONNEL. THIS DEVICE IS ALSO DIFFICULT TO HANDLE SINCE IT HAS NO GUIDE TO ADVANCE THE CATHETER. IN THIS HOSPITALIZATION UNIT, TRAINING WILL BE REINFORCED WITH THE HEALTHCARE STAFF IN THE USE AND HANDLING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194415 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3296534 00382903883110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown