MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS CLOSED MALE LUER, 10 UNITS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	CH2000S-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation, it is pending investigation.
Event or Problem Description
The customer reported that the spiros leaked leaked while pushing doxorubicin.The leak occurred on the luer connection between spiros and syringe.There was patient involvement but no reported harm, the only patient exposure was 2 drops on patient's sweater.The chemotherapy spill was cleaned up per protocol; however, a spill kit was not used.There was no adverse event or delay in therapy.
Additional Manufacturer Narrative
Received one used device for evaluation.Drug leakage was observed and confirmed at the connection between the female luer of the ch2000s-10 spinning spiros and the male luer of the 30ml luer lock syringe.It was noted that male luer threads of the luer lock syringe and the threads of the ch2000s-10 spinning spiros were not engaged suggesting a disconnect during use.There was no thread damage on the 30ml luer lock syringe and no luer or spin feature damage on the ch2000s-10 spinning spiros.The spinning spiros met product performance expectations for leak resistance.The probable cause of the disconnect resulting in leakage cannot be determined.The lot review was performed with no issues noted.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, 10 UNITS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 12134350
• Report Number: 9617594-2021-00187
• Device Sequence Number: 4131068
• Product Code: FPA
• UDI-Device Identifier: 00840619033910
• UDI-Public: (01)00840619033910(17)260501(10)5355596
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: CH2000S-10
• Device Catalogue Number: CH2000S-10
• Device Lot Number: 5355596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DOXORUBICIN, UNK MFR.