MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 113" (287 CM) APPX 14.7 ML, 10 DROP ADMIN SET W/MICROCLAVE¿ CLEAR, REMV 4-WAY NA; STOPCOCK, I.V. SET

Catalog Number	AC233
Medical Device Problem Code	Disconnection (1171)
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
Although the multiple attempts were requested for the device to be returned for evaluation, it has not been received.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a 113" (287 cm) appx 14.7 ml, 10 drop admin set w/microclave¿ clear, remv 4-way nanoclave¿ stopcock, remv 2-gang 4-way nanoclave¿ stopcocks, spin luer, 2 ext.The report stated that the stopcocks are falling apart and disconnecting.There was no report of any human harm.
Additional Manufacturer Narrative
No ac233 product samples, videos or photographs were returned for investigation.The device history report (dhr) was not reviewed, no lot number information was provided.The complaint cannot be confirmed, without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

• Brand Name: 113" (287 CM) APPX 14.7 ML, 10 DROP ADMIN SET W/MICROCLAVE¿ CLEAR, REMV 4-WAY NA
• 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: 20421403
• Report Number: 9617594-2024-01423
• Device Sequence Number: 8257699
• Product Code: FMG
• UDI-Device Identifier: 00887709120174
• UDI-Public: 00887709120174
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: AC233
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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