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

Catalog Number	CH2000S-PC
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation; device history review is still pending.
Event or Problem Description
The event occurred on an unspecified date and involved a spinning spiros® closed male luer, purple cap where the customer reported that the device separated/disconnected from the line ¿ chemo (ganciclovir) leaks out of the giving set during patient use.The reporter mentioned that there was no visible damage observed on the set that caused the separation/disconnection.There was unprotected chemotherapy exposure to the patient, health care worker or other personnel.Spills are always cleaned as per local policy using a spill kit.Interventions relating to patient included changing lines and making a plan for lost chemotherapy.When asked if the set was replaced and therapy resumed without any problem, the customer responded that it depends on the chemotherapy and situation, and when possible, different lines are used however this was often not feasible due to loss of chemotherapy in the line itself so it had to be cleaned and reconnected which goes against recommended best practice for central line cares and infection prevention.There was patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
No ch2000sc-pc product samples, videos or photographs were returned for investigation.The device history record 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.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, PURPLE 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: 20346517
• Report Number: 9617594-2024-01366
• Device Sequence Number: 7895692
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)270201(10)5824001
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 5824001
• 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: 09/02/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: GANCICLOVIR, MFR UNK; GANCICLOVIR, MFR UNK; UNSPECIFIED IV LINE/GIVING SET, MFR UNK
• Patient Sex: Unknown