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

Catalog Number	CH2000SC-10
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of no flow / can't prime / difficult to prime on item ch2000sc-10 could not be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history report (dhr) lot#5985409 was reviewed and no non conformities were found that would have led the reported complaint.F2 - uf/importer report #: (b)(4).
Event or Problem Description
The event involved a spiros®, closed male luer w/red cap, 10 units where the customer reported that the closed system transfer device did not allow fluid movement.After multiple attempts, a replacement was used and worked correctly.There was patient involvement but no harm to patient or staff.

• Brand Name: SPIROS®, CLOSED MALE LUER W/RED CAP, 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18053747
• Report Number: 9617594-2023-00925
• Device Sequence Number: 6877569
• Product Code: FPA
• UDI-Device Identifier: 00840619042769
• UDI-Public: (01)00840619042769(17)270501(10)5985409
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/04/2023

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 Catalogue Number: CH2000SC-10
• Device Lot Number: 5985409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown