BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP

    MDR report key: 8691972 · Received June 12, 2019

    Report

    Report Number
    9617594-2019-00173
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 8, 2019
    Report Date
    May 21, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: NO CH2000S-PC PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DHRS FOR LOTS 3553926, 3905536, 3803605, 3520162, 3972775, 3653544 AND 3667618 WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR TESTING AND INVESTIGATION. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER IDENTIFIED SEVEN POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 3553926 (EXPIRY DATE 11/01/2022 , MFR DATE 11/01/2017), 3905536 (EXPIRY DATE 12/01/2023, MFR DATE 12/01/2018), 3803605 (EXPIRY DATE 10/01/2023, MFR DATE 10/01/2018), 3520162 (EXPIRY DATE 08/01/2022, MFR DATE 08/01/2017), 3972775 (EXPIRY DATE 02/01/2024, MFR DATE 02/01/2019), 3653544 (EXPIRY DATE 04/01/2023, MFR DATE 04/01/2018) AND 3667618 (EXPIRY DATE 05/01/2023, MFR DATE 05/01/2018). THE DEVICE HISTORY REVIEW (DHR) FOR LOTS 3553926, 3905536, 3803605, 3520162, 3972775, 3653544 AND 3667618 WERE REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT INVOLVED LEAKAGE OF CHEMOTHERAPY, EPIRUBICIN, FROM THE DISTAL SIDE AT THE LEVEL OF THE SPIROS. A (B)(6) YEAR OLD PATIENT WAS RECEIVING CHEMOTHERAPY VIA IMPLANTABLE INJECTION CHAMBER TO TREAT BREAST CANCER. DURING THE ADMINISTRATION OF THE SECOND SYRINGE OF EPIRUBICIN, 3/4TH OF THE CYTOTOXIC MEDICATION SPILLED ON THE GROUND AND SOME DROPS CAME INTO CONTACT WITH THE PATIENTS ARM. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A SKIN REACTION AND THERE WAS NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE CHEMO EXPOSURE. THE PATIENT RETURNED THE FOLLOWING DAY TO COMPLETE THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485458 SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR EPIRUBICIN.