BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 8566273 · Received April 30, 2019

    Report

    Report Number
    1911916-2019-00424
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 12, 2019
    Report Date
    April 16, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED. IT HAS RESIDUES OF DRIED BLOOD FROM THE LUER TO THE BOTTOM OF THE RUBBER STOPPER. THIS INDICATES THE SYRINGE WAS USED TO DRAW BLOOD. THE PLUNGER ROD- RUBBER STOPPER SEPARATION IS 3/32¿. FAILURE MODE IS VERIFIED HOWEVER, IT IS OF NOTE THAT THE POSIFLUSH PRODUCT IS DESIGNED TO FLUSH THE LINES, NOT FOR DRAWING BLOOD. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 2ND COMPLAINT FOR THE LOT# 8172883 FOR THE SAME DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 8172883 DURING THE PRODUCTION RUN. ROOT CAUSE DESCRIPTION: FAILURE MODE IS VERIFIED HOWEVER, IT IS OF NOTE THAT THE POSIFLUSH PRODUCT IS DESIGNED TO FLUSH THE LINES, NOT FOR DRAWING BLOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 2 OCCURRENCES WHERE THE PLUNGER SEPARATED WITH A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PLUNGER SEPARATED FROM THE BLACK RUBBER STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360844 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8172883 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Other