BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES

    MDR report key: 15497247 · Received September 28, 2022

    Report

    Report Number
    1911916-2022-00530
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    September 7, 2022
    Report Date
    September 28, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE HAD MOLD AND DISCOLORATION. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW TWO POSIFLUSH SYRINGES IN SEALED PACKAGING FLOW WRAPS. EACH HAS A TIP CAP WITH DISCOLORATION; ONE IS YELLOWISH AND THE OTHER ONE IS BLACK. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT NUMBER 2193626. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM OF FOREIGN MATTER REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES, MOLD WAS FOUND ON THE SYRINGES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEALED FLUSH HAS MOLD. IT DOES SEEM TO HAVE PENETRATED INSIDE TOO. THE WHOLE BOX HAS BEEN QUARANTINED AND NOTHING WAS DISPENSED TO ANY PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES, MOLD WAS FOUND ON THE SYRINGES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEALED FLUSH HAS MOLD. IT DOES SEEM TO HAVE PENETRATED INSIDE TOO. THE WHOLE BOX HAS BEEN QUARANTINED AND NOTHING WAS DISPENSED TO ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584593 BD POSIFLUSH¿ NORMAL SALINE SYRINGES SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 2193626 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown