MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.58 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 0.2 MIC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC330532
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - this complaint was received through: (b)(6).The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a 9" (23 cm) appx 0.58 ml, smallbore bifuse ext set w/2 microclave¿ clear, 0.2 micron filter, 2 clamps, rotating luer that experienced crack and leakage.It was reported that there was a crack on the filter, causing the tpn fluid to leak.There was patient involvement and no human harm.
Additional Manufacturer Narrative
Received one used list #mc330532, 9" (23 cm) appx 0.58 ml, smallbore bifuse ext set w/2 microclave¿ clear, 0.2 micron filter, 2 clamps, rotating luer.As received, the outlet filter was observed to be wetted out.The reported complaint of a leak could be confirmed.The returned sample was tested, and a leak was observed on the inline filter.The probable cause is from the temporary loss of hydrophobic properties.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 05may2025 corrected information can be found in d2, d10 concomitant products and g2 - report source g4 - pma/510(k) #.

• Brand Name: 9" (23 CM) APPX 0.58 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 0.2 MIC
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 21945496
• Report Number: 9617594-2025-00877
• Device Sequence Number: 21005416
• Product Code: FPA
• UDI-Device Identifier: 00887709092457
• UDI-Public: (01)00887709092457(17)291101(10)14211693
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: MC330532
• Device Lot Number: 14211693
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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: TPN, MFR UNK.
• Patient Sex: Unknown