BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH

    MDR report key: 20433440 · Received October 11, 2024

    Report

    Report Number
    9610048-2024-00158
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 20, 2024
    Report Date
    February 10, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883363
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38833614 AND LOT NUMBER 4024128. 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, FOUR (4) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, THE TIP OF THE CATHETER CONTAINED A STAIN AND WHEN ENLARGED, THE PICTURES SHOWED SILICONE AND BLACK DOTS ON THE CATHETER. A PROBABLE CAUSE FOR THE OBSERVED DEFECT MAY BE RELATED TO AN EXCESSIVE AMOUNT OF SILICONE DISPENSED DURING THE SILICONIZATION PROCESS OF THE CATHETER. IT SHOULD BE NOTED THAT THE SILICONE DOES NOT CAUSE HARM AND IS USED TO HELP THE CATHETER SLIDE DURING VENIPUNCTURE. THE DIRT FOUND ON THE CATHETER ¿BLACK SPOTS¿ MAY BE RELATED TO DIRT ON THE WALL OF THE MACHINE IN THE GRID FEEDER. DURING THE FEEDING OF THE CATHETER GRIDS, WHEN THE MACHINE VIBRATES (A NORMAL PROCESS OF THE MACHINE) THE CATHETERS MAY TOUCH THE WALL. IN THE HYPOTHESIS THAT THIS FEEDING WALL IS NOT PROPERLY CLEANED, IF THE CATHETER TOUCHES THE WALL, DIRT MAY RESULT IN THE CATHETER. THE RELATED ASSOCIATES IN THE ANGIOCATH PRODUCTION AREA WERE MADE AWARE OF THE IMPORTANCE OF PROPER CLEANING OF THE MACHINE TO PREVENT ANY DEFECT OF THIS NATURE FROM REACHING THE CUSTOMER. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ANGIOCATH FOREIGN MATTER NOTED ON CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WHEN OPENING THE CATHETER AND OBSERVING WHAT SURROUNDS THE PROBE (SILICONE), IT HAS BLACK DOTS, BUT WHEN I LIGHTLY SCRAPE MY FINGERNAIL, THEY COME OUT, SO IT IS BELIEVED TO BE DIRT ON THE SILICONE OF THE CATHETER. WHAT PART/COMPONENT/PART OF THE PRODUCT IS INVOLVED IN THE COMPLAINT? CATHETER SILICONE. PURPOSE OF USE: IN WHICH PROCEDURE WAS THE MATERIAL BEING OR WOULD IT BE USED? INTRAVENOUS PUNCTURE IN PATIENT. IN WHICH SITUATION WAS THE DEVIATION IDENTIFIED? BEFORE STARTING ANY PROCEDURE WITH THE MATERIAL AND WITHOUT CONTACT WITH THE PATIENT/PROFESSIONAL. WAS THERE ANY DAMAGE TO THE HEALTH OF THE PATIENT OR THE PROFESSIONAL WHO HANDLED THE MATERIAL? NO. WAS THERE A NEED FOR MEDICAL INTERVENTION? NO. WAS SURGICAL INTERVENTION NECESSARY? NO. WAS THERE A NEED FOR IMPATIENT OR PROLONGED HOSPITALIZATION? NO. WAS THERE EXPOSURE TO CHEMICAL/BIOLOGICAL AGENTS (REGARDLESS OF THE USE OF PPE)? NO. WAS THERE AN ACCIDENTAL PUNCTURE WITH THE PROBE? NO. DID THE EVENT LEAD TO DEATH? NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326561 BD ANGIOCATH PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4024128 00382903883363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown