MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12"(30CM)APPX 0.77ML, SMALLBORE EXT SET W/CLAVE®, 0.22 MICRON FILTER, CLAMP, ROT; STOPCOCK, I.V. SET

Catalog Number	Z2599
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 12"(30cm)appx 0.77ml, smallbore ext set w/clave®, 0.22 micron filter, clamp, rotating luer.The reporter stated that after starting an intravenous (iv) infusion with the aforementioned device, unspecified fluids started leaking at the connection between the filter and the patient¿s peripherally inserted central catheter (picc) because the male luer was broken and not secured/sealed around the line and this was discovered after disconnecting the tubing.There was no report of any human harm.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
The complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.An image was provided by the customer showing the label of the product.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Updated information in d9.

• Brand Name: 12"(30CM)APPX 0.77ML, SMALLBORE EXT SET W/CLAVE®, 0.22 MICRON FILTER, CLAMP, ROT
• 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: 21601890
• Report Number: 9617594-2025-00469
• Device Sequence Number: 21233054
• Product Code: FMG
• UDI-Device Identifier: 00887709027091
• UDI-Public: (01)00887709027091(17)291201(10)14237190
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/19/2025

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: Z2599
• Device Lot Number: 14237190
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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: UNSPECIFIED FLUIDS/INFUSATE, MFR UNK; UNSPECIFIED PICC LINE, MFR UNK
• Patient Sex: Unknown