BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNING SPIROS CLOSED MALE LUER, RED CAP

    MDR report key: 10358159 · Received August 3, 2020

    Report

    Report Number
    9617594-2020-00279
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    June 22, 2020
    Report Date
    July 8, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026615
    PMA / PMN Number
    K082806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ONE (1) USED LIST# CH2000S-C, SPINNING SPIROS® CLOSED MALE LUER, RED CAP. LOT# 4763174 CONNECTED TO 0NE (1) USED BD SYRINGE 30 ML WAS RECEIVED ON JULY 28, 2020 FOR EVALUATION. MULTIPLE PHOTOS WERE RETURNED SHOWING A USED CH2000S-C SPINNING SPIROS CONNECTED TO A SYRINGE WITH RED DRUG IN THE BARREL. LEAKAGE WAS VISIBLE WITHIN THE CH2000S-C SPINNING SPIROS ASSEMBLY. THE USED SPINNING SPIROS WAS FUNCTIONALLY TESTED. WATER WAS DRAW UP THROUGH THE USED CH2000S-C SPINNING SPIROS AND INTO THE BARREL OF THE 30ML SYRINGE. WHILE DEPRESSING THE PLUNGER SLIGHTLY TO SIMULATE A DRUG PUSH, THE USED CH2000S-C SPINNING SPIROS WAS LIGHTLY MANIPULATED WITH NORMAL BENDING AND TWISTING FORCES. LEAKAGE WAS OBSERVED AT THE INTERFACE BETWEEN THE POPPET AND O-RING SEAL. THE PROBABLE CAUSE OF THE LEAKING SPIROS IS DUE TO A MOLDING ANOMALY ON THE SEALING SURFACE OF THE POPPET SUB-COMPONENT. ALL OTHER MATING DEVICES RETURNED WERE MEASURED/EVALUATED AND NO ANOMALIES OR DEFECTS WERE OBSERVED. A DEVICE HISTORY REVIEW FOR LOT# 4763174 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE FOLLOWING MATING DEVICES WERE ALSO RETURNED: FIVE (5) NEW BD CONNECTA 10 CM, REF# 394995, LOT# 9282186, ONE (1) USED BD CONNECTA 10 CM. REF# 394995, LOT# 9282186, SEVEN (7) NEW PROMEDICARE, REF# 805.1281 PM HP 3000, LOT# 27 19 12, TWO (2) NEW CH-74, LOCKING UNIVERSAL VENTED VIAL SPIKE, CLAVE®. LOT# 4720458, ONE (1) NEW BD PLASTIPAK 30 ML REF# 301229, LOT# 2001295. ALL OTHER MATING DEVICES RETURNED WERE MEASURED/EVALUATED AND NO ANOMALIES OR DEFECTS WERE OBSERVED. ADDITIONAL INFORMATION IN H7. THE LIST AND LOT NUMBER OF THE DEVICE WAS IDENTIFIED AS PART OF A VOLUNTARY RECALL. ICU MEDICAL IS NOTIFYING AFFECTED CUSTOMERS VIA A LETTER REQUIRING REMOVAL OF THE AFFECTED PRODUCTS FROM THE MARKET.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION. IT IS YET TO BE RECEIVED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN THE IN-PATIENT WARD AND INVOLVED A SPINNING SPIROS, CLOSED MALE LUER, RED CAP THAT LEAKED WHILE ADMINISTERING AN IV BOLUS INJECTION OF DOXORUBICIN. THE DOSE HAD TO BE ABANDONED. THERE WAS PATIENT AND STAFF INVOLVEMENT, BUT NO HARM REPORTED. THE CHEMO DRUG DID NOT COME INTO CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THE SPILL WAS CLEANED USING A SPILL KIT ACCORDING TO THE GUIDELINES. THIS EVENT CAPTURES THE FIRST EVENT ON THE FIRST DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820388 SPINNING SPIROS CLOSED MALE LUER, RED CAP SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4763174 00840619026615

    Patients

    Seq Age Sex Outcome Treatment
    1 50ML SYRINGE, BD| DOXORUBICIN, MFR UNK