BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 18738370 · Received February 20, 2024

    Report

    Report Number
    9610048-2024-00019
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    January 23, 2024
    Report Date
    June 7, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    MDS-24-5036-FA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 38831114 AND LOT NUMBER 3062305. ALTHOUGH NO QUALITY NOTIFICATIONS OR NON-CONFORMITY REPORTS WERE DOCUMENTED DURING THE PRODUCTION PROCESS, A CORRECTIVE MAINTENANCE ACTION WAS PERFORMED DURING THE MANUFACTURING PERIOD. THE MAINTENANCE ACTION PERFORMED VARIOUS ADJUSTMENTS AND ALIGNMENTS THAT MAY HAVE BEEN RELATED TO THIS DEFECT. AS SAMPLES WERE UNAVAILABLE FOR THIS EVENT, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE PROVIDED INFORMATION, IT HAS BEEN DETERMINED THAT THIS INCIDENT IS RELATED TO THE CATHETER TIP NOT BEING COMPLETELY FORMED DURING THE MANUFACTURING PROCESS. WE ARE CONDUCTING A VOLUNTARY RECALL OF THE AFFECTED CATHETERS BD INSYTE FOR CERTAIN CATALOGS AND LOT NUMBERS. THE AFFECTED CATHETER TIP MAY RESULT IN RESISTANCE WITH THE CATHETER INSERTION PROCESS. THE POTENTIAL IMMEDIATE HEALTH CONSEQUENCES ASSOCIATED WITH THE ABOVE, INCLUDE PAIN /DISCOMFORT, VESSEL INJURY, VASCULITIS, TISSUE INJURY, BLEEDING, DELAY IN PROCEDURE AND NEED FOR ADDITIONAL DEVICE INSERTION. IT IS ALSO POSSIBLE FOR THERE TO BE NO HEALTH EFFECTS RELATED TO THE USE OF THE STRAIGHT EDGED TIP. LONG TERM HEALTH CONSEQUENCES WOULD NOT BE EXPECTED; HOWEVER, MAY BE PRESENT ONLY AS A RESULT OF THE IMMEDIATE HEALTH CONSEQUENCE. IT IS RECOMMENDED THAT CLINICIANS USE STANDARD CLINICAL PRACTICE OF INSPECTION OF THE DEVICE PRIOR TO INSERTION. IF THE CLINICIAN DOES NOT NOTICE THE CATHETER TIP EDGE, THEY ARE INSTRUCTED TO STOP THE INSERTION PROCEDURE IF PAIN OR RESISTANCE OUT OF PROPORTION TO THE PROCEDURE IS NOTED. IF A DEFECTIVE PRODUCT IS INSERTED, MONITORING FOR TISSUE, VESSEL AND SKIN DAMAGE IS RECOMMENDED. IF ANY SYMPTOMS OCCUR, IT IS RECOMMENDED TO REMOVE THE PRODUCT AND REPLACE WITH A NEW PRODUCT IF CLINICALLY INDICATED. WE ARE INVESTIGATING AND WILL IMPLEMENT APPROPRIATE MEASURES TO PREVENT RECURRENCE OF THIS PRODUCT ISSUE. A CORRECTIVE AND PREVENTIVE ACTION PLAN IS IN PROGRESS. PRODUCTION PERSONNEL HAVE BEEN INFORMED OF THE PRODUCT ISSUE AND RETRAINED TO THE PROCEDURES TO INCREASE AWARENESS. PLEASE SEE THE PROVIDED RECALL NOTICE (MDS-24-5036-FA) FOR FURTHER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE CATHETER TIP IS MALFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: INSTITUTION REPORTING FAILURE OF INSYTE 24 DESCRIBE KINKING OF THE POLYURETHANE CANNULA IN THE SKIN AFTER THE PUNCTURE, DUE TO THE FACT THAT THE TIP OF THE CATHETER IS NOT CONICAL, ATTACHED FORMS OF THE INSTITUTION, MORE THAN 13 COMPLAINTS IN PEDIATRIC PATIENT AND FAMILY EXPERIENCE, WITH TWO OFFICIAL FORMATS OF THE INSTITUTION. DAMAGE TO THE PLASTIC (TUBING) IS EVIDENT WHEN THE CATHETERS ARE OPENED AND TESTED. MULTIPUNCH DUE TO DEVICE FAILURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299353 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3062305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown