MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE®, 4 CLAMPS, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B33294
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event involved a 4" smallbore quadfuse ext set w/4 microclave®, 4 clamps, rotating luer where the reporter stated that the silicone stuck down for the quadfuse, and one was cracked where the clave bonded with the extension during patient use.It was also stated that the product had been on a patient for six (6) days.It was used to infuse all medications going into the peripherally inserted central catheter (picc) line which included tpn, lipids, and cafcit, and there was no leaking reported.There was patient involvement, unknown human harm and unknown delay according to the report.
Additional Manufacturer Narrative
The device has been requested for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
The reported complaint of a stick down could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.Lot history review was not conducted as a lot number was not provided.
Additional Manufacturer Narrative
G3 - correction to mdr due date.

• Brand Name: 4" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE®, 4 CLAMPS, ROTATING LUER
• 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: 22653451
• Report Number: 9617594-2025-01556
• Device Sequence Number: 18312213
• Product Code: FMG
• UDI-Device Identifier: 00887709007307
• UDI-Public: (01)00887709007307
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 10/13/2025

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: B33294
• Device Lot Number: NOT PROVIDED
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 10/07/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/09/2025; 10/15/2025
• 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