BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 11128958 · Received January 6, 2021

    Report

    Report Number
    1911916-2020-01170
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 9, 2020
    Report Date
    December 14, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306575 AND LOT NUMBER 0230777. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. RATIONALE: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% HAD DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNABLE TO INSTILL NS FULLY FROM SYRINGE. SIGNIFICANT RESISTANCE, REMOVED FROM PATIENT CATHETER, AND TESTED, REMAINED RESISTANT. STOPPED AT ~ 3ML MARK OF 10 ML PREFILLED NS SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19090 BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0230777

    Patients

    Seq Age Sex Outcome Treatment
    1