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 Code	Disconnection (1171)
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
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The incident involved a spinning spiros closed male luer purple cap on an unknown date.The customer stated that there were several reports between december 2019 and first semester of 2020 where the product had a defective screw thread.The product does not lock, leading to disconnection.There was unknown patient involvement, but no harm was reported.
Additional Manufacturer Narrative
The customer's report of disconnection could not be confirmed during testing.A used ch2000s-pc spinning spiros was returned securely connected to a 5ml luer lock syringe.Although the customer reported that no leakage was noted, leakage was identified during testing.The leaking occurred at the poppet/o-ring interface in both the unactivated and activated positions.The spinning spiros assembly was disassembled and the o-ring outside diameter was found to be undersized and out of specification.This dimensional inaccuracy could result in leakage.The probable cause of the leakage is an o-ring molding inaccuracy during molding in salt lake city.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to mfr 9-aug-2023.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17389465
• Report Number: 9617594-2023-00432
• Device Sequence Number: 3875147
• Product Code: ONB
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)240401(10)4040723
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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: 04/01/2024
• Device Catalogue Number: CH2000S-PC
• Device Lot Number: 4040723
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• 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