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	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint involving a 71" (180 cm) appx 0.44 ml, smallbore ext set w/microclave® clear, clamp (blue), rotating luer experienced air in line.The reporter stated that their patient was getting iv antibiotics via syringe pump.The ns flush was placed on the pump after the antibiotic was done infusing and flush started.Patient's mother then noticed about 6 inches of air in the line after the ns flush started.They unhooked the line from the patient so that no air got through the iv and into the patient.The patient's mother also stated that this exact situation happened the night before.There was patient involvement, no patient or staff harm / injury.
Additional Manufacturer Narrative
D1 brand name - 71" (180 cm) appx 0.44 ml, smallbore ext set w/microclave® clear, clamp (blue), rotating luer.H6 - the device has not yet been received, upon receiving the device, an investigation will be completed.When complete, then a supplemental mdr will be submitted.
Additional Manufacturer Narrative
A couple of photos were shared by the customer, the item and lot information are shown, no damage or anomalies are observed based on the photo.One (1) used sample# (b)(6) was returned for evaluation.As received normal saline was observed inside the set.No physical damage was observed.No mating device was returned for evaluation.The sample was tested as per procedure and no leaks, air bubbles was observed after the test.Complaint of air in the line cannot be confirmed or replicated.The device history lot #13916143 review was performed, and no relevant, discrepancies or nonconformances were identified that might lead the condition reported by the customer.

• 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: 20243161
• Report Number: 9617594-2024-01310
• Device Sequence Number: 20673957
• Product Code: FMG
• UDI-Device Identifier: 00887709088344
• UDI-Public: (01)00887709088344(17)290201(10)13916143
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: MC330428
• Device Lot Number: 13916143
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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