BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 10571314 · Received September 22, 2020

    Report

    Report Number
    1911916-2020-00893
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 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 0072581. 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. INVESTIGATION CONCLUSION: NO SAMPLES WERE RECEIVED. NO PHOTOS WERE PROVIDED. THEREFORE, SAMPLE ANALYSIS COULDN¿T BE PERFORMED, AND THE SYMPTOM REPORTED BY THE CUSTOMER CAN¿T BE CONFIRMED. A REVIEW OF THE APPLICABLE FMEA/EURA (B)(4) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION. ROOT CAUSE DESCRIPTION: WITH NO SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. RATIONALE: BASED ON THE INVESTIGATION PERFORMED AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED; WE WILL CONTINUE MONITORING AND TRENDING THE COMPLAINTS TO THIS LOT AND SYMPTOM THIS LOT WAS PRODUCED FOR 360.9K UNITS, THIS IS A CPM OF 2.7.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIVE 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGES EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT CANNOT BE PUSHED WHEN HALFWAY THROUGH THE BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035569 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE PREFILLED SALINE SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0072581

    Patients

    Seq Age Sex Outcome Treatment
    1 Other