MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.69 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC9004
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported that, on an unknown date, a 9" (23 cm) appx 0.77 ml, pressure infusion (400psig) ext set w/remv microclave¿ clear, clave¿ clear, clamp, rotating luer generated a leak during patient use.The report stated that they are claiming that when drawing blood, they noticed that blood squirts out from the proximal removable microclave when disconnected.There was no patient harm reported.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video, a comprehensive review cannot be performed, and a probable cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 9" (23 CM) APPX 0.69 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: 20177473
• Report Number: 9617594-2024-01273
• Device Sequence Number: 8722909
• Product Code: FPA
• UDI-Device Identifier: 00887709039315
• UDI-Public: (01)00887709039315(17)290601(10)14049397
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 12/09/2024

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: MC9004
• Device Lot Number: 14049397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2024
• 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