MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS,; STOPCOCK, I.V. SET

Catalog Number	011-MC3316
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
The event occurred on an unspecified date and involved a 6" (15cm) appx 0.33ml, smallbore bifuse ext set w/2 microclave¿ clear, 3 clamps, rotating luer that experienced no flow.The customer reported malfunctions in the functioning of the two and three-way micro clave extension, which manifests itself as hemodynamic instability of the patient and the error message ¿ ¿occlusion on the perfusor¿.When the extension is replaced, the patient's condition normalizes.The problem has occurred in several cases (unspecified quantity).The event occurred during infusion.No serious injury or death.No blood loss and no unprotected chemo exposure.There was delay in critical therapy.No adverse operator consequences and no med/surg intervention required.The device was changed out/replaced with no further problems encountered.The product is stored in the storage area, monitored and has all the necessary certifications (iso standards etc.) there were no cuts, holes, defects noted on the product.
Additional Manufacturer Narrative
Received five used 011-mc3316 smallbore bifuse ext sets and one 3 ml syringe for complaint investigation.No defects or anomalies noted.Each of the returned devices were filled with fluid and used to inject through each microclave on the 011-mc3323 trifuse ext sets.There were no restrictions in flow.The reported complaint was not replicated or confirmed.The dhr was reviewed and no relevant non-conformities were found that would have led to the reported complaint.Corrected information can be found in d10 and e3.

• Brand Name: 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿ CLEAR, 3 CLAMPS,
• 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: 21652279
• Report Number: 9617594-2025-00516
• Device Sequence Number: 9511300
• Product Code: FMG
• UDI-Device Identifier: 00840619043230
• UDI-Public: (01)00840619043230(17)280101(10)13518371
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 011-MC3316
• Device Lot Number: 13518371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED "PERFUSOR" (INFUSION PUMP), MFR UNK.
• Patient Sex: Unknown