BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-EXT SET 15CM SMALL BORE SPIN NUT

    MDR report key: 12147374 · Received July 9, 2021

    Report

    Report Number
    9610847-2021-00317
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 8, 2021
    Report Date
    October 13, 2021
    Product Code
    FPA
    UDI-DI
    00382903851638
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-07-23 D4: MEDICAL DEVICE LOT #: 0121421 D4: MEDICAL DEVICE EXPIRATION DATE: 2023-04-30 H4: DEVICE MANUFACTURE DATE: 2020-05-26 D4: MEDICAL DEVICE LOT #: 0092897 D4: MEDICAL DEVICE EXPIRATION DATE: 2023-03-31 H4: DEVICE MANUFACTURE DATE: 2020-05-26 D4: MEDICAL DEVICE LOT #: 0272324 D4: MEDICAL DEVICE EXPIRATION DATE: 2023-09-30 H4: DEVICE MANUFACTURE DATE: 2020-10-13 H6: INVESTIGATION SUMMARY BD RECEIVED TWO SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE WAS NOT CONFIRMED UPON INSPECTION AND LEAKAGE TESTING OF THE SAMPLES. SINCE THE REPORTED FAILURE WAS NOT CONFIRMED A ROOT CAUSE CANNOT BE ESTABLISHED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF BATCHES 0121421, 0272324. BATCH 0092897 HAD A QUALITY NOTIFICATION FOR ¿SEPTUM WITHIN HOUSING¿, BUT NEITHER OF THE SAMPLES SHOW THAT DEFECT. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. SEE H10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO ADDITIONAL INFORMATION: B.3. DATE OF EVENT: 6/8/2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BI-EXT SET 15CM SMALL BORE SPIN NUT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE DURING ADMINISTRATION OF CHEMO (CISPLATIN), LEAKAGE AT THE LEVEL OF QSYTE. MRS. HAD LIQUID (CHEMO) ON HER GARMENT, FURTHER WORKED ACCORDING TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BI-EXT SET 15CM SMALL BORE SPIN NUT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE DURING ADMINISTRATION OF CHEMO (CISPLATIN), LEAKAGE AT THE LEVEL OF QSYTE. MRS. HAD LIQUID (CHEMO) ON HER GARMENT, FURTHER WORKED ACCORDING TO PROCEDURE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BI-EXT SET 15CM SMALL BORE SPIN NUT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE DURING ADMINISTRATION OF CHEMO (CISPLATIN), LEAKAGE AT THE LEVEL OF QSYTE. MRS. HAD LIQUID (CHEMO) ON HER GARMENT, FURTHER WORKED ACCORDING TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038361 BI-EXT SET 15CM SMALL BORE SPIN NUT INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN 00382903851638

    Patients

    Seq Age Sex Outcome Treatment
    1