BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 10610945 · Received September 30, 2020

    Report

    Report Number
    1911916-2020-00910
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 11, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 306547 AND LOT NUMBER 0191862. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE PHYSICAL SAMPLE AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE TWO PHOTOS SHOW THE SAMPLE RECEIVED WITH FOREIGN MATTER. THE PHYSICAL SAMPLE CAME WITH NO FLOW WRAP AND INSIDE A PLASTIC BAG. A VISUAL INSPECTION WAS PERFORMED AND THE FOREIGN MATTER WAS SEEN FLOATING IN THE SALINE SOLUTION. FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED ON THE FOREIGN MATTER IN AN ATTEMPT TO IDENTIFY THE PARTICLE¿S COMPOSITION. THE ANALYSIS OF THE LABORATORY CAME BACK WITH THE BEST MATCH AS POLYESTER. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE NO MATERIALS USED IN THE FILL ROOM MADE OUT OF POLYESTER. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. THE SAMPLE WAS PASSED THROUGH THE INSPECTION MACHINE AND WAS REJECTED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: ONE SAMPLE WAS RECEIVED. IT CAME WITH NO PACKAGING FLOW WRAP AND INSIDE OF A PLASTIC BAG. VISUAL INSPECTION WAS PERFORMED. THERE IS A FOREIGN MATTER FLOATING IN THE SALINE SOLUTION. THE SAMPLE WILL BE SENT TO A LAB FOR ANALYSIS. THE ANALYSIS OF THE LABORATORY CAME WITH THE BEST MATCH AS POLYESTER. THE SAMPLE WAS PASSED THROUGH THE INSPECTION MACHINE AND IT WAS REJECTED. A REVIEW OF THE APPLICABLE FMEA/EURA ((B)(4)) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. ROOT CAUSE DESCRIPTION: UNKNOWN. NONE OF THE MATERIALS USED IN THE FILLROOM ARE MADE OUT OF POLYESTER. RATIONALE: BASED ON THE INVESTIGATION CARRIED OUT AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL BE MONITORING THE COMPLAINT TREND FOR THIS LOT. THIS LOT WAS PRODUCED FOR 1.6MM UNITS; THEREFORE, THE CPM IS 0.62.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLOATING FOREIGN MATTER WAS SEEN IN THE SEALED BD POSIFLUSH¿ NORMAL SALINE SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE A SYRINGE THAT HAS A FLOATER IN IT. IT IS SEALED, NOT USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068818 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306547 0191862 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Other