BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 10796366 · Received November 5, 2020

    Report

    Report Number
    1911916-2020-01011
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    August 15, 2020
    Report Date
    November 3, 2020
    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

    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 306595 AND LOT NUMBER 9140980. 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. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION CARRIED OUT AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE LOT AND SYMPTOM. ROOT CAUSE DESCRIPTION: WITH NO SAMPLE RECEIVED AND NO PHOTO PROVIDED A POTENTIAL ROOT CAUSE COULD NOT BE OFFERED. THIS LOT WAS PRODUCED FOR (B)(4) UNITS; THEREFORE, THE CPM IS (B)(4). 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¿ NORMAL SALINE SYRINGE TIP CAP WAS FOUND TO BE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE NURSE PERFORMED PICC MAINTENANCE FOR THE PATIENT, THE STERILIZATION WAS COMPLETE, AND THE FLUSH WAS USED TO FLUSH THE TUBE FOR THE PATIENT. IT CANNOT BE CONNECTED TO THE POSITIVE PRESSURE CONNECTOR. REPLACED THE NEW IRRIGATOR. THE BOLUS WAS SUCCESSFULLY INJECTED, THE FLUSH WAS CHECKED, AND THE TIP CAP OF THE FLUSH WAS FOUND TO BE BROKEN, AND THE HEAD NURSE WAS INFORMED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254836 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9140980

    Patients

    Seq Age Sex Outcome Treatment
    1