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	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer that experienced leakage during use.The report states that "bedside rn was changing tubing and had blood backing up into the line.Line began leaking with flush and rn noticed cracked extension tube".The patient involved is a 0.04 year old male.The packaging was not saved.No other devices being used on the patient at the time of the event that may have caused or contributed to the event.Sample was available for evaluation.There was patient involvement and no adverse event.Nch tracking number (b)(4).
Additional Manufacturer Narrative
A2 - date of birth - the patients age was given as 0.04 years old.This was used to approximate the date of birth as (b)(6) 2025 the device has been received for evaluation.The investigation is pending completion.
Additional Manufacturer Narrative
Investigation summary received 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 #unknown.A crack was observed on the female luer.The reported complaint of a leak could be confirmed.The returned extension set was observed to have a crack on the female luer.The probable cause is due to a material issue on a vendor supplied part.The lot # review could not be conducted because no lot number(s) was/were identified.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.

• 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: 22120352
• Report Number: 9617594-2025-01130
• Device Sequence Number: 14495936
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/31/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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
• Patient Age: 15 DA
• Patient Sex: Male