BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 10659742 · Received October 9, 2020

    Report

    Report Number
    1911916-2020-00948
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 22, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 30654678 AND LOT NUMBER 0190656. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT PLUNGER MOVEMENT DIFFICULT. TO AID IN THE INVESTIGATION, TWO PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE CAME WITH NO FLOW WRAP, NO TIP CAP, NO SOLUTION AND RUBBER STOPPER ALL THE WAY DOWN. THE OTHER SAMPLE CAME IN SEALED PACKAGING FLOW WRAP. BOTH WERE TESTED FOR SUSTAINING FORCE AND ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, THE SAMPLES RECEIVED DID NOT SHOW THE DEFECT REPORTED BY THE CUSTOMER. 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: 2 SAMPLES WERE RECEIVED. ONE CAME WITH NO PACKAGING FLOW WRAP, NO TIP CAP, AND NO SOLUTION. THE RUBBER STOPPER IS ALL THE WAY DOWN. IT WAS TESTED FOR SUSTAINING FORCE GIVING 12.2N; THE OTHER SAMPLE CAME IN SEALED PACKAGING FLOW WRAP. IT WAS TESTED FOR SUSTAINING FORCE GIVING 9.4N. THE SPECIFICATION IS <20N. 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: PROBABLE ROOT CAUSE IS UNKNOWN, THE SAMPLES RECEIVED WERE WITHIN THE PRODUCT SPECIFICATION. RATIONALE: BASED ON THE INVESTIGATION CARRIED OUT AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS LOT. THIS LOT WAS PRODUCED FOR 1.63MM UNITS; THEREFORE, THE CPM IS 0.61.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 10ML REG PR SALINE 10ML FILL EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED COMPLAINTS FROM THE LAB AND THE ED REGARDING THE 10 ML PRE-FILLED SALINE SYRINGE 30654678 (LOT# 0190656). STAFF ARE EXPERIENCING ISSUES WITH THE PLUNGER BEING DIFFICULT TO PUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123966 SYRINGE 10ML REG PR SALINE 10ML FILL PREFILLED SALINE SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0190656 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other