MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 132" (335 CM) APPX 17.4 ML, 20 DROP ADMIN SET W/3 CLAVE¿ CLEAR, REMV 3-GANG NANO; STOPCOCK, I.V. SET

Catalog Number	AC236
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.However, photographs were provided by the customer and evaluation of the photos is pending.
Event or Problem Description
The complaint/event involved a 132" (335 cm) appx 17.4 ml, 20 drop admin set w/3 clave¿ clear, remv 3-gang nanoclave¿ stopcock w/baseplate, spin luer, 2 ext.It was reported that the 3-gang nanoclave broke off where the string was attached.The issue happened post-case, while removing the lines for disposal.There was patient involvement, however, there was no human harm and no delay in therapy.
Additional Manufacturer Narrative
One photograph was returned for evaluation.The customer's reported condition of crack/break was able to be confirmed through the photo sample.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Lot history review was performed and there were no non-conformance's found that would have contributed to the reported complaint.

• Brand Name: 132" (335 CM) APPX 17.4 ML, 20 DROP ADMIN SET W/3 CLAVE¿ CLEAR, REMV 3-GANG NANO
• Common Device Name: STOPCOCK, I.V. SET
• 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: 20813837
• Report Number: 9617594-2024-01711
• Device Sequence Number: 21317323
• Product Code: FMG
• UDI-Device Identifier: 00887709122895
• UDI-Public: (01)00887709122895(17)290401(10)13972370
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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
• Report Date (Section B): 12/30/2024

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: AC236
• Device Lot Number: 13972370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/30/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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