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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - date of birth - the patients age was used to approximate the date of birth as (b)(6) 2025.Investigation summary one (1) used partial.List # mc33213 (without microclave) was returned for evaluation.As received, a crack on the female luer tubing fitment was observed.No additional damage or anomalies were observed.No mating device was returned for evaluation.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Complaint of small crack in j loop can be confirmed or replicated.The probable cause is due to a material issue on a vendor supplied part.
Event or Problem Description
A complaint was received regarding a to 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer that experienced crack.The report states that there is a small crack in j loop ¿ closest to parent.The involved patient is 0-day-old male.The affected area/unit location is in mcsa nicu.The packaging was saved.This is not a single use device that was reprocessed and reused on a patient.Sample was available for evaluation.The device will be returned via the manufacturer¿s preferred return process.The device involved in this event was not available in their facility.Date of occurrence was on 14-mar-2025.It was in use for patient care.No other devices being used on the patient at the time of the event that may have caused or contributed to the event.There was patient involvement and no adverse event.

• 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: 21931478
• Report Number: 9617594-2025-00862
• Device Sequence Number: 18305530
• Product Code: FPA
• UDI-Device Identifier: 00887709037519
• UDI-Public: (01)00887709037519(17)270801(10)7154211
• 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
• Report Date (Section B): 04/29/2025

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: 7154211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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: 13 DA
• Patient Sex: Male