MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR (RED,; STOPCOCK, I.V. SET

Catalog Number	MC330375
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that a 6.5" (17 cm) appx 1.1 ml, smallbore quadfuse ext set w/4 microclave¿ clear (red, purple, tpn rings), 0.2 micron filter, 1.2 micron filter, 4 clamps, check valve, luer lock generated a leak during patient use.It was stated in the report that the product problem was leaking total parental nutrition (tpn).There was no patient harm reported.
Additional Manufacturer Narrative
Received photos from the customer of paperwork and label.No conclusions could be made from the received photos.One used.List #mc330375, 6.5" (17 cm) appx 1.1 ml, smallbore quadfuse ext set w/4 microclave¿ clear (red, purple, tpn rings), 0.2 micron filter, 1.2 micron filter, 4 clamps, check valve, luer lock; lot #13551095 was received and tested.One of the samples was observed to have a leak.The reported complaint of a leak could be confirmed during testing.The probable cause of the leak is from an incomplete insertion during assembly.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 6.5" (17 CM) APPX 1.1 ML, SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR (RED,
• 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: 20213787
• Report Number: 9617594-2024-01297
• Device Sequence Number: 7774371
• Product Code: FMG
• UDI-Device Identifier: 00887709085671
• UDI-Public: (01)00887709085671(17)280301(10)13551095
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: MC330375
• Device Lot Number: 13551095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: TPN, UNK MFR.
• Patient Sex: Unknown