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	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
A medsun medwatch mandatory and voluntary report with uf/importer report # (b)(4) on (b)(6) 2025, which stated: ¿from staff: primary ivf [intravenous fluids] (d10w) backing up into med-line.Med-line leaking at the filter.A wet area was found on the floor in the patient room, and it was noted to be sticky.The charge nurse traced the tubing back to the filter where it was found to be leaking.The rn flushed the set to be sure it was leaking and found it was indeed leaking at the filter.¿ the date of the event was not specified.Preexisting characteristics that may have contributed to the event: premature infant.The suspected medical device was a 60" smallbore ext set w/0.2 micron filter, clamp, luer lock.
Additional Manufacturer Narrative
D9 - device available for evaluation: no.Investigation summary the reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 22519459
• Report Number: 9617594-2025-01468
• Device Sequence Number: 13069200
• Product Code: FMG
• UDI-Device Identifier: 00887709003491
• UDI-Public: (01)00887709003491(17)281001(10)13802315
• 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): 09/23/2025

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: 13802315
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: D10W IV FLUIDS, MFR UNK.; UNSPECIFIED PRIMARY IV LINE, MFR UNK.
• Patient Age: 2 DA
• Patient Sex: Unknown
• Patient Weight: 3 KG