MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33150
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 7" (18cm) appx 0.24ml, smallbore pressure infusion (400psig) ext set w/microclave¿ clear, purple clamp, rotating luer where it was reported that there was a crack on the j-loop.There was patient involvement, and no human harm.
Additional Manufacturer Narrative
One used, list #mc33150, was returned for evaluation, as it received an unknown solution, and a bump/crack was observed on shuntless microclave.No mating device was returned for evaluation.The set was tested as per procedure and no leaks were observed.Complaint of crack can be confirmed.However, how, when, or where this break occurs is unknown.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 7" (18CM) APPX 0.24ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAV
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19709478
• Report Number: 9617594-2024-00883
• Device Sequence Number: 12471372
• Product Code: FPA
• UDI-Device Identifier: 00887709037441
• UDI-Public: (01)00887709037441(17)290201(10)13903520
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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: MC33150
• Device Lot Number: 13903520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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
• Patient Sex: Unknown