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

Catalog Number	20130-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a spinning spiros® closed male luer, red cap.The customer reported that one of the spiros, which was connected to a smith¿s cadd, had been leaking on a patient for 24 hours while they were asleep.There was presence of blood on the tubing and spiros, along with potential traces of fluorouracil.There was patient involvement and unknown harm/adverse event reported.The event occurred on (b)(6) 2024; however, it was only noted on (b)(6) 2024.The patient wasn¿t harmed, just got some fluorouracil on their skin and some bedding.It was a first time cadd for the patient and they were worried about having the same pump put back on for fear of it leaking again.Mostly just concern from the patient.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.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 cause cannot be determined.The device history report (dhr) was reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, RED CAP
• 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: 19826834
• Report Number: 9617594-2024-00940
• Device Sequence Number: 15627081
• Product Code: FPA
• UDI-Device Identifier: 00840619023386
• UDI-Public: (01)00840619023386(17)290101(10)13866731
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 20130-01
• Device Lot Number: 13866731
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CADD, SMITH'S MEDICAL; FLUOROURACIL (5FU), MFR UNK
• Patient Sex: Unknown