BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 12319114 · Received August 13, 2021

    Report

    Report Number
    1911916-2021-00817
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 16, 2021
    Report Date
    August 6, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065479
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: IT WAS REPORTED TWO SYRINGES FROM THIS LOT WERE DOUBLE LABELED. TO AID IN THE INVESTIGATION, FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH A DOUBLE BARREL LABEL. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306547, LOT NUMBER 1053587. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. OPERATORS WERE INFORMED ABOUT THIS COMPLAINT. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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. ROOT CAUSE DESCRIPTION: PROBABLE ROOT CAUSE. IT COULD BE POSSIBLE THAT A JAM OCCURRED AT THE LABELER MACHINE INDUCING THE DOUBLE BARREL LABEL AND NOT DETECTED IN THE NEXT PROCESSES. THE EQUIPMENT HAS A SENSOR TO VERIFY THAT A BARREL LABEL HAS BEEN PLACED; HOWEVER, IT DOESN'T VERIFY FOR DOUBLE LABELING. THIS WOULD BE DETECTED IN THE NEXT INSPECTIONS. OPERATORS WERE INFORMED ABOUT THIS COMPLAINT. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL WERE DOUBLE-LABELED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED TWO SYRINGES FROM THIS LOT WHICH WERE DOUBLE-LABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217425 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1053587 00382903065479

    Patients

    Seq Age Sex Outcome Treatment
    1