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

Model Number	CH2000-PC
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not yet been received.A review of a customer-provided photo is pending.
Event or Problem Description
The event occurred on an unspecified date and involved a spiros closed male luer, purple cap.The complainant reported that there was a leaking issue on this closed system drug-transfer device (ctsd) and lab testing was requested.There was no report of human harm.
Additional Manufacturer Narrative
No product samples were returned for investigation.A photograph was returned showing the label side of a ch2000-pc spinning spiros.No product was visible on the photograph, only the unit package label.Without the return of the affected sample, a detailed investigation cannot be completed and a probable cause cannot be determined based on the information that has been provided.The device history record (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.
Additional Manufacturer Narrative
The complaint investigation has been updated with the following information: the following items were returned by the customer for complaint investigation: twelve new list #ch2000-pc, spiros® closed male luer, purple cap; lot #5333905 no mating devices were returned to evaluate with the new ch2000-pc spiros.No anomalies were noted on any of the twelve new ch2000-pc spiros.Each of the return devices were subsequently leak tested.No leakage was observed in either the activated or unactivated positions.The complaint of leakage was unable to confirmed or replicated during lab/complaint testing.The device history record was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.D9 - date returned to mfg: 02oct2023.

• Brand Name: 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17305054
• Report Number: 9617594-2023-00349
• Device Sequence Number: 7213473
• Product Code: ONB
• UDI-Device Identifier: 00840619023812
• UDI-Public: (01)00840619023812(17)260601(10)5333905
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2023

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 Expiration Date: 06/01/2026
• Device Model Number: CH2000-PC
• Device Catalogue Number: CH2000-PC
• Device Lot Number: 5333905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/22/2023; 11/03/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/15/2023; 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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