MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4.5" (11 CM) APPX 0.53 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 C; STOPCOCK, I.V. SET

Catalog Number	MC330087
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Event or Problem Description
The event occurred on an unspecified date involving a 4.5" (11 cm) appx 0.53 ml, smallbore quadfuse ext set w/4 microclave® clear, 4 clamps (red, yellow, white, blue), rotating luer where the customer reported that they had an issue of clave stick-down.The 3 of the 4 microclaves were noted to stuck down with forward flow through each arm stopped.There was unknown patient involvement and unknown harm.
Additional Manufacturer Narrative
Investigation summary received one (1) used mc330087 smallbore quadfuse ext set w/4 microclaves for inspection.As received, three (3) of the four (4) microclaves were stuck down.Each microclave was accessed with a syringe and fluid was infused.There were no restrictions in flow and each of the microclave seals rebounded after disconnection.Each of the stuck down microclaves were disassembled and the spike tips were found to have insufficient lubricant.The reported complaint of a stickdown can be confirmed on the mc330087.The probable cause is due to insufficient lubricant applied during assembly in salt lake city.A device history review for the lot # and relevant commodities were reviewed and no relevant non-conformities were found that would have led to the reported complaint.

• Brand Name: 4.5" (11 CM) APPX 0.53 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 4 C
• 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: 20316477
• Report Number: 9617594-2024-01348
• Device Sequence Number: 18057390
• Product Code: FMG
• UDI-Device Identifier: 00887709077010
• UDI-Public: (01)00887709077010(17)281001(10)13781578
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: MC330087
• Device Lot Number: 13781578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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