MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33122
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sixty-one (61) new.List #mc33122, 7" were returned for evaluation were returned for evaluation.As received no damage was observed.The 35 samples item #mc33122, 7" were taken based on the binomial stages sampling to represent the lot population, these samples were tested as per procedure and once time activated from the microclaves and no leaks or anomalies were observed.Complaints of leaks cannot be confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
It was reported that, on an unknown date, a 7" (18 cm) appx 0.51 ml, pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer generated a leak during patient use.The report stated that this product was leaking.The sample is available for investigation.There was no patient harm reported.

• Brand Name: 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®
• 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: 19544604
• Report Number: 9617594-2024-00770
• Device Sequence Number: 12683048
• Product Code: FPA
• UDI-Device Identifier: 00887709037403
• UDI-Public: (01)00887709037403(17)270101(10)13810366
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2024

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: MC33122
• Device Lot Number: 13810366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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