MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE),; STOPCOCK, I.V. SET

Catalog Number	MC330428
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 71" (180 cm) appx 0.44 ml, smallbore ext set w/microclave® clear, clamp (blue), rotating luer which the customer reported that the medication line was leaking from the point of connection.Tylenol and a flush had been run before the small leak was noticed.It was not specified if there was patient involvement or not, however, no injury was repoted as a consequence of this event.
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Additional Manufacturer Narrative
The single used mc330428 extension set was pressure leak tested and there were no leaks observed at any location along the fluid path.The male spin luer was measured and it met design expectations.No mating devices were returned to evaluate with the used mc330428 extension set.The complaint was unable to be replicated or confirmed during lab testing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 71" (180 CM) APPX 0.44 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP (BLUE),
• 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: 17814785
• Report Number: 9617594-2023-00748
• Device Sequence Number: 6205739
• Product Code: FMG
• UDI-Device Identifier: 00887709088344
• UDI-Public: (01)00887709088344(17)280401(10)13598837
• Combination Product (Y/N): N
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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: MC330428
• Device Lot Number: 13598837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TYLENOL AND FLUSH MEDICATION, MFR UNK
• Patient Sex: Unknown