MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH2000S-PC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 and h4 the catalog#, lot#, expiration date, and manufacture date are unknown.
Event or Problem Description
It was stated that unspecified spiros experienced disconnection.It was stated that "as we discussed we have had numerous issues with spiros disconnecting from the rest of the giving set ¿ this has occurred from all potential parts of the set but in particular from y connectors.So far, this has always been from the side where the purple cap is.This has been encountered when attached to patients with chemotherapy running.When investigating, grace and i have found the spiros to disconnect from the y-connector when we are holding it in our hands." the event occurred during chemotherapy running.The handling / use of the product of the event occur was during use on patient.Other products involved at the time of event was the bifurcated minibore extension set where the manufacturer was codan.Someone become aware of the issue when tubing noted to be disconnected with patient treatment, also noted when being primed for administration.There was medication being used with this product and it was chemotherapy.Stated that they have a sample that was used in the videos, and it was not contaminated.There are 2 videos showing the spiro unscrewing by there was patient involvement but no adverse event and no delay in therapy.
Additional Manufacturer Narrative
Additional information in d1, d4, d9, & h4.Two (2) videos were provided showing the spiros disconnecting from the needleless access devices with no interaction.The spiros did not appear to be fully connected to the needleless access devices in either video.The reported complaint can be confirmed.The probable cause is unknown.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21030552
• Report Number: 9617594-2024-01866
• Device Sequence Number: 3968908
• Product Code: ONB
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)270201(10)5812303
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: CH2000S-PC
• Device Lot Number: 5812303
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED MINIBORE EXT, BC2148, CODAN.
• Patient Sex: Unknown