BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES

    MDR report key: 13965037 · Received March 31, 2022

    Report

    Report Number
    1911916-2022-00170
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    February 13, 2022
    Report Date
    March 17, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306594 AND LOT NUMBER 1152081. 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. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. 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. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. WITH NO SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES THE SYRINGE WAS FOUND TO BE DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PREPARING THE PATIENT FOR TREATMENT, A NURSE DISCOVERED THAT THE FLUSH SYRINGE WAS PARTIALLY MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872510 BD POSIFLUSH¿ NORMAL SALINE SYRINGES SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1152081

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown