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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer where it was reported the device had a crack and leaked.A patient was having a gi procedure and was receiving sedation and iv fluids.It was reported the peripheral intravenous (piv) tubing was hooked up to the patient, anesthesia went to push medications through it, the meds and fluid started to spray out of the side of the j loop plastic piece that connects into the medication luer lock cap on it.It was then noticed there was a crack, however, this was not noticed during priming.There were no other devices being used on a patient at the time of event that may have caused or contributed to the event.There was patient involvement, but no harm reported.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.
Additional Manufacturer Narrative
Received one (1) used mc33213 smallbore ext set for inspection.A crack was observed on the female luer.The reported complaint of leakage can be confirmed due to the crack found.The probable cause is due to a material issue on a vendor supplied part.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.
Additional Manufacturer Narrative
Updated information in sections e and g.
Event or Problem Description
Received a medsun medwatch uf/importer report # (b)(4) on 06-aug-2025.

• 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 ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22193584
• Report Number: 9617594-2025-01214
• Device Sequence Number: 8837036
• Product Code: FPA
• UDI-Device Identifier: 00887709037519
• UDI-Public: 00887709037519
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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: MC33213
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 08/06/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/22/2025; 09/09/2025
• 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: LACTATED RINGERS, UNK MFR.; PIV TUBING, UNK MFR.; UNSPECIFIED SEDATION, UNK MFR.
• Patient Age: 7 YR
• Patient Sex: Male