BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SP

    MDR report key: 21459968 · Received February 25, 2025

    Report

    Report Number
    3002682307-2025-00026
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 8, 2025
    Report Date
    March 31, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FOZ
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO AID IN THE INVESTIGATION OF THIS ISSUE, THE PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE RECEIVED SHOWED A LONG BROWNISH PARTICLE INSIDE OF THE SYRINGE. ALONGSIDE THE SAMPLE CONTAINING THE FOREIGN MATTER, THERE WAS THE ORIGINAL POSIFLUSH SYRINGE IN WHICH THE CUSTOMER STATED THEY FOUND THE PARTICLE. THE SAMPLE WAS SENT FOR FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY TO IDENTIFY THE FOREIGN MATTER COMPOSITION. HOWEVER, FOREIGN MATTER WOULD NOT BE ACCURATELY IDENTIFIED BASED ON THE MATERIAL LIBRARIES AVAILABLE WITH THE FTIR ANALYSIS. THE FOREIGN PARTICLE HAS A 39-40% COINCIDENCE WITH POLY VINYL ACETATE IN VARIOUS FORMS AND IDENTIFIED PARTIALLY AS METHYLPHENIDATE HCL IN KBR AND DI(PROPYLENE GLYCOL) METHYL ETHER ACETATE. POLY VINYL ACETATE IS A THERMOPLASTIC MATERIAL THAT IS NORMALLY USED FOR COATING. METHYLPHENIDATE HCL IS A PSYCHOSTIMULANT USED TO TREAT DIFFERENT BEHAVIORAL DISORDERS SO THIS CAN BE DISCARDED SINCE IT IS A CROSS-CONTAMINATION. DI(PROPYLENE GLYCOL) METHYL ETHER ACETATE CAN BE EMPLOYED AS A SOLVENT IN COATINGS AND SILK-SCREENING INKS. IT IS ALSO USED AS A CLEANING AGENT. THIS COMPONENT IS ALSO DISCARDED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 4311190. 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. THEREFORE, NO SPECIFIC CIRCUMSTANCES FROM THE MANUFACTURING PROCESS COULD BE FOUND TO EXPLAIN THE DESCRIBED EVENT. THE MANUFACTURING SITE HAS SEVERAL POINTS WITHIN THE MANUFACTURING LINE TO AVOID CONTAMINATION OF THE SALINE SOLUTION. WITHIN THE FILLING AREA, BARRELS ARE AIR WASHED SO NO PARTICLES ARE LEFT INSIDE AND STOPPERS ARE WASHED PRIOR TO FILLING WITH SALINE SOLUTION. HIGH-EFFICIENCY PARTICULATE AIR (HEPA) FILTERS ARE LOCATED WITHIN THE FILL ROOMS. ALL SYRINGES ARE INSPECTED FOR PARTICULATES WITHIN THE SALINE SOLUTION AND FOR EMBEDDED PARTICLES. ALL SYRINGES ARE INSPECTED FOR FOREIGN MATTER WITHIN THE SALINE. THE INSPECTION MACHINE DETECTS PARTICLES OF POLYPROPYLENE AND RUBBER OF 200-400 MICROMETERS AND 800-1000 MICROMETERS IN SIZE. IT ALSO DETECTS FIBERS OF 3X5MM. VISUAL INSPECTIONS ARE PERFORMED FROM THE FILLING TO PACKAGING PROCESS. MOREOVER, AN ON-SITE FLOW PROCESS REVIEW DID NOT IDENTIFY ANY STEP IN THE PROCESS WHICH COULD ORIGINATE THE REPORTED FOREIGN MATTER. THE PIPING SYSTEM AND TUBES OF THE FILLING AREA ARE MADE OF STAINLESS STEEL IN ORDER TO AVOID ANY PARTICLE RELEASE INTO THE EQUIPMENT AND THEREFORE, PREVENT CONTAMINATION. BASED ON THE INVESTIGATION RESULTS, THE EXACT NATURE OF THE PARTICLE COULD NOT BE DETERMINED AND THEREFORE, THE SOURCE OF CONTAMINATION COULD NOT BE DETERMINED. THE ONLY POSSIBLE SOURCE AS PER INFORMATION AVAILABLE IS A CONTAMINATION OF THE STOPPER COMPONENT FROM THE SUPPLIER. IF A PARTICLE REMAINS IN THE STOPPER AFTER WASHING, AND IT IS STUCK WITHOUT RELEASE INTO THE SOLUTION DURING THE 100% INSPECTION, THE PARTICLE COULD BE PACKAGED. THIS IS A VERY UNUSUAL CIRCUMSTANCE. 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.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH-SP FOREIGN MATTER NOTED IN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE EACH OF A 10ML BD FLUSH SYRINGE WAS FOUND WITH CONTAMINATION INSIDE THE SYRINGE. A NURSE AT XXX NOTICED CONTAMINATION IN THE 10ML SYRINGE PRIOR TO ADMINISTERING TO A PATIENT. THE NURSE DID NOT ADMINISTER TO THE PATIENT AND IMMEDIATELY NOTIFIED THE CHARGE NURSE / AR. TO BETTER EXAMINE THE CONTAMINATE, THE NURSE DREW IT INTO A SMALLER SYRINGE FOR INSPECTION. THE ORIGINAL 10ML SYRINGE HAD BEEN PULLED FROM THE CLEAN SUPPLY ROOM SHORTLY BEFORE USE. ASSESSMENT: SUPPLY CHAIN IS CONTACTING AS MANY AR'S AS POSSIBLE TO PULL AND SEQUESTER THE IMPACTED LOT IN AN ABUNDANCE OF CAUTION. WE WILL PARTNER WITH IN INFECTION PREVENTION LEADERSHIP AND CLINICAL LEADERSHIP ON NOTIFICATION AND SAFETY MEASURES FOR THE STATE. CONVENIENCE LOCATIONS, NURSE SERVERS, SPECIALTY CART DRAWERS, PATIENT ROOM DRAWERS, ETC. WILL NEED TO BE EXAMINED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029111 BD POSIFLUSH SP SALINE VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON, S.A. 4311190 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown