BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE¿ 5ML SALINE FILL

    MDR report key: 9559001 · Received January 7, 2020

    Report

    Report Number
    1911916-2020-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 30, 2019
    Report Date
    January 7, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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 2ND COMPLAINT FOR LOT # 9140777 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). 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 THE LABEL WAS MISSING ON THE BARREL WITH A BD SYRINGE¿ 5ML SALINE FILL. THIS OCCURRED WITH 3 SYRINGES PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE SECOND AFFILIATED HOSPITAL OF HARBIN MEDICAL UNIVERSITY HAD A FLUSH COMPLAINT IN THE SECOND WARD OF PEDIATRIC MEDICAL DEPARTMENT ON THE MORNING OF DECEMBER 30TH. THE FLUSH¿S BATCH NUMBER WAS 9140777. THE PROCESS OF COMPLAINTS WAS AS FOLLOWS: WHEN THE NURSE WAS DOING FLUSHING CATHETER IN THE MORNING, SHE FOUND THAT THERE WAS NO LABEL ON TH BARREL WHEN OPENING THE FLUSH'S PACKAGE. DURING ROUTINE NURSING IN THE MORNING, SHE FOUND 3 CASES OF FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24911 BD SYRINGE¿ 5ML SALINE FILL SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 9140777

    Patients

    Seq Age Sex Outcome Treatment
    1 Other