MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B2155
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.
Event or Problem Description
An event occurred on an unspecified date in (b)(6) 2025 involving a 60" smallbore ext set w/ 0.2 micron filter, clamp, luer lock reported that while checking the lines for an infant patient, the rn noticed that the medication tubing was wet.The registered nurse replaced the tubing when preparing to administer an intravenous medication.During the shift change and nurse handoff, the newly installed tubing was also found to be wet.Further inspection revealed leakage around the filter, possibly due to a crack in the filter.The previous tubing was also retrieved and inspected to also be leaking around the filter.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video, a probable cause cannot be determined.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Updated information in d9.

• Brand Name: 60" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, LUER LOCK
• 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: 23653395
• Report Number: 9617594-2025-02226
• Device Sequence Number: 11968245
• Product Code: FMG
• UDI-Device Identifier: 00887709003491
• UDI-Public: (01)00887709003491(17)300301(10)14329474
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: B2155
• Device Lot Number: 14329474
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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: POSI FLUSH, BD LIST # 306546 LOT # 5162459.; UNSPECIFIED MEDICATION, UNK MFR.
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 3 KG