MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" (24 CM) APPX 0.56 ML, SMALLBORE EXT SET W/NANOCLAVE®, 0.2 MICRON FILTER, CL; STOPCOCK, I.V. SET

Catalog Number	A1202
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that, on an unknown date, a 9.5" (24 cm) appx 0.56 ml, smallbore ext set w/nanoclave¿, 0.2 micron filter, clamp, luer lock generated a leak during patient use.The report stated that the small bore extension set filter was noted to be leaking.There was no patient harm reported.
Additional Manufacturer Narrative
The complaint on the a1202 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) for lot 13796426 was conducted and no nonconformities were found that would have led to the reported complaint.D9 - device available for evaluation: no.

• Brand Name: 9.5" (24 CM) APPX 0.56 ML, SMALLBORE EXT SET W/NANOCLAVE®, 0.2 MICRON FILTER, CL
• 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: 19442703
• Report Number: 9617594-2024-00718
• Device Sequence Number: 18295591
• Product Code: FMG
• UDI-Device Identifier: 00887709080706
• UDI-Public: (01)00887709080706(17)281001(10)13796426
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/29/2024

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: A1202
• Device Lot Number: 13796426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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: UNSPECIFIED FLUID, UNK MFR
• Patient Sex: Unknown