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	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the day was not given only august 2024.01 aug 2024 has been used as a placeholder.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A event regarding a spiros¿, closed male luer w/red cap, 10 units experienced no flow during infusion.It was reported: ¿while making a hazardous chemotherapy drug.Primed the line and attached a spiros.Registered nurse (rn) sent the mixture back for occlusions halfway through the infusion.Spiros was faulty if at a certain angle it would allow flow but if moved it would not created a problem since this admixture was time sensitive and needed to be completely infused within 90 minutes.No patient harm.¿ additional event information obtained from ufmw: the report was completed by pamela harding a risk manager of honorhealth scottsdale shea medical center.The outcome attributed to adverse event was other serious or important medical events.This is a product problem with the event date aug-2024.The event occurred in the hospital.There was patient involvement and no adverse event.Medwatch uf/importer report # (b)(4).
Additional Manufacturer Narrative
Medsun medwatch uf/importer report #(b)(4).No ch2000sc-10 product samples, videos or photographs were returned for investigation.The device history report (dhr) was 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
Correction: the medsun medwatch uf/importer report is now in h10 instead of in h11 from the previous submitted report.

• 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: 20626416
• Report Number: 9617594-2024-01567
• Device Sequence Number: 7553448
• Product Code: FPA
• UDI-Device Identifier: 00840619042769
• UDI-Public: (01)00840619042769(17)281101(10)13835963
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2025

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: 13835963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 01/28/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/03/2024; 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown