BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD

    MDR report key: 9832849 · Received March 14, 2020

    Report

    Report Number
    1911916-2020-00249
    Event Type
    Malfunction
    Date Received
    March 14, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 3, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903064991
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 9002664 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: UNDETERMINED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRS 10 ML FIL SALINE SHORTLENGTH PLUNGER RODS EXPERIENCED SYRINGE VOLUMETRIC ACCURACY ISSUES WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306499 BATCH NO: 9002664. CUSTOMER STATED THAT THE SYRINGE IS OFF BY .4 - .6ML WHEN ASPIRATED WITH MEDICATION. HE REPORTED THIS HAPPENING BEFORE BUT SAID NOTHING CAME OF IT. HE STATES THIS HAS BEEN HAPPENING SINCE NOVEMBER 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296538 SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD INTRAVASCULAR CATHETER NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9002664 00382903064991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other