MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" SMALLBORE HEXAFUSE EXT SET W/6 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 6 C; STOPCOCK, I.V. SET

Catalog Number	A1145
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 12" smallbore hexafuse ext set w/6 microclave® clear, nanoclave® (red ring), 6 check valves, 7 clamps (green, 2 yellow, blue, light green, 2 white) luer lock where it was reported that the hex set was found leaking above clave.Bed saturated with total parenteral nutrition (tpn) fluid that was running through the line.The defect was in hex set.It was not a single use device that was reprocessed and reused on a patient.The device was in use for patient care.No other device being used on the patient at the time of event that may cause or contributed to the event.There was patient involvement and unknown adverse event.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Additional Manufacturer Narrative
Received one used list# a1145, 12" smallbore hexafuse ext set w/6 microclave® clear, nanoclave® (red ring), 6 check valves, 7 clamps (green, 2 yellow, blue, light green, 2 white) luer lock; lot# 14089229 from the customer for complaint investigation.No visual damages or anomalies were observed on the returned device.The reported complaint of a leak was confirmed.The line with a yellow clip paired with the white clip leaked during testing.The probable cause of the leak is from an incomplete insertion during the assembly process of manufacturing.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 12" SMALLBORE HEXAFUSE EXT SET W/6 MICROCLAVE® CLEAR, NANOCLAVE® (RED RING), 6 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: 20884809
• Report Number: 9617594-2024-01751
• Device Sequence Number: 18403043
• Product Code: FMG
• UDI-Device Identifier: 00887709070103
• UDI-Public: (01)00887709070103(17)290701(10)14089229
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/16/2025

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: A1145
• Device Lot Number: 14089229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TOTAL PARENTERAL NUTRITION, UNK MFR
• Patient Age: 4 MO
• Patient Sex: Male