BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PRE-FILLED NORMAL SALINE SYRINGE

    MDR report key: 10121510 · Received June 4, 2020

    Report

    Report Number
    1911916-2020-00527
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 1, 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: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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: BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THIS IS THE 1ST COMPLAINT FOR LOT # 9140980 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "WHITE GRANULAR OBJECT" WAS SEEN INSIDE THE BD¿ PRE-FILLED NORMAL SALINE SYRINGE DURING USE WHEN "PUSHING HARD" ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE NURSE USED THE FLUSH TO SEAL THE PATIENT'S CATHETER AT 11:20, THE INFUSION WAS SUCCESSFULLY CARRIED OUT. WHEN RETURNING TO THE TREATMENT, PUSHED HARD, WHITE GRANULAR OBJECT APPEARED INSIDE, CONSIDERED THE FLUSH WAS BLOCKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585634 BD¿ PRE-FILLED NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9140980

    Patients

    Seq Age Sex Outcome Treatment
    1 Other