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

Model Number	CH2000S-PC
Medical Device Problem Codes	Contamination (1120); Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a spinning spiros closed male luer, red cap in which the customer reported that they tried using a vial spike and noticed a small fragment of clear plastic along with a hole that can be seen when disconnected from the spiros.The customer suspects that spiros device may cause the silicon to become loose.It was not specified whether there was patient involvement or not.No harm was reported as a consequence of this event.
Additional Manufacturer Narrative
The device was discarded and not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Additional telephone number - section e1 (b)(6).
Additional Manufacturer Narrative
A photo was provided for evaluation; the complaint of cored seal on a a clave can be confirmed based on the photos provided.The photo showed clave (concomitant product) with a cored silicone seal.No spiros can be observed in the photos provided.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review for lot 5957596 was reviewed and no non conformities 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16860184
• Report Number: 9617594-2023-00172
• Device Sequence Number: 5796298
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)270501(10)5957596
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 04/11/2023

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 Model Number: CH2000S-PC
• Device Catalogue Number: CH2000S-C
• Device Lot Number: 5957596
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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: VIAL SPIKE, LIST # 011-CH74 - ICU MEDICAL.
• Patient Sex: Unknown