MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33213
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An incident was reported with a smallbore pressure infusion extension set in which fluid was leaking at the connection point between the microclave cap and the loop.The microclave cap was first replaced with one from another j-loop of the same lot, but the leak persisted when flushed with 0.9% normal saline.Microclave cap changed again from a single microclave cap package and continued to leak.Entire set up changed to a y-connector and then there was no longer a leak.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
The device has been requested for evaluation, however, it has not yet been received.
Additional Manufacturer Narrative
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.Lot history review was conducted, and no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
One (1) used.List #mc33213, 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer; lot #14178886.No visual damages or anomalies were observed.One (1) used.List #mc33213, 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer; lot #14178886.--> one (1) used.Ref #306547, 0.9% sodium chloride bd posiflush 10 ml syringe; lot #5237684.The infusion set was observed to have a crack on the female luer.The reported complaint of a leak could be confirmed.The returned sample was observed to have a crack on the female luer.The probable cause is due to a material issue on a vendor supplied part.A corrective and preventative action (capa) plan has been implemented to address the identified issue.The outcome of the capa is currently under evaluation and is not yet finalized.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
Correction: d9 - date returned to mfr: 1/26/2026, e4 - initial report sent to fda - updated to yes, h10 - related report numbers - medsun number added: (b)(4).H11 - investigation summary update: one (1) used.List #mc33213, 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer; lot #14178886.No visual damages or anomalies were observed.One (1) used.List #mc33213, 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer; lot #14178886.One (1) used.Ref #306547, 0.9% sodium chloride bd posiflush 10 ml syringe; lot #5237684.The infusion set was observed to have a crack on the female luer.The reported complaint of a leak could be confirmed.The returned sample was observed to have a crack on the female luer.The probable cause is due to a material issue on a vendor supplied part.A corrective and preventative action (capa) plan has been implemented to address the identified issue.The outcome of the capa is currently under evaluation and is not yet finalized.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
H10 - related report number (b)(4) listed on previous emdr was incorrect and should not have been documented.

• Brand Name: 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI
• 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 ; .; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23904083
• Report Number: 9617594-2025-02335
• Device Sequence Number: 20766377
• Product Code: FPA
• UDI-Device Identifier: 00887709037519
• UDI-Public: (01)00887709037519(17)291001(10)14178886
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/29/2026

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: MC33213
• Device Lot Number: 14178886
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 03/03/2026; 03/03/2026; 04/20/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/19/2026; 03/13/2026; 03/25/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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: 0.9% NORMAL SALINE, UNK MFR.
• Patient Sex: Unknown