MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.39 ML, PUR YELLOW SMALLBORE EXT SET W/CLAVE¿ CLEAR, 1.2 MICRON; STOPCOCK, I.V. SET

Catalog Number	MC330715
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number unknown.
Event or Problem Description
The event involved a 9" (23 cm) appx 0.39 ml, pur yellow smallbore ext set w/clave¿ clear, 1.2 micron filter, clamp, luer loc.It was reported that the filter set 9" has leaking at the filter.Filter was on under 12 hours of use when leaking occurred.Someone became aware of the issue when liquid was found on the filter and on the bed.The customer stated that the products have trifuse attached, and the connection at the microclave was leaking behind the microclave on where the tubing is bonded with glue to the connector.There was no medication being used with the product but tpn was used with the filter at time of the event.There was patient involvement, there was delay in therapy, no adverse event, and no one was harmed as a result of the reported event.
Additional Manufacturer Narrative
Received one used list# mc330715, 9" (23 cm) appx 0.39 ml, pur yellow smallbore ext set w/clave clear, 1.2 micron filter, clamp, luer lock; lot# unknown.No visual damages or anomalies were observed.The reported complaint of a leak at the filter could be confirmed.The sample was leak tested and a leak was observed at the filter.The probable cause of the leak is from the temporary loss of hydrophobic properties during use.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 9" (23 CM) APPX 0.39 ML, PUR YELLOW SMALLBORE EXT SET W/CLAVE¿ CLEAR, 1.2 MICRON
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21049227
• Report Number: 9617594-2024-01925
• Device Sequence Number: 3278998
• Product Code: FMG
• UDI-Device Identifier: 00887709127197
• UDI-Public: (01)00887709127197
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/12/2025

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: MC330715
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown