MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 18 CM (7") APPX 0.43 ML, PRESSURE INFUSION EXT SET W/SURPLUG¿ MICRO CLEAR, ROTAT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	IH-EH41810
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was leakage with the pressure infusion ext set w/surplug¿ micro clear.There was unknown patient involvement and unknown patient harm.
Additional Manufacturer Narrative
D4, g4: model number is not sold in the us but similar device is sold under model: b33122.This product was used for the di and 501k.E1: this complaint was received through: (b)(6).Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
Additional information was received stating that the event occurred in dynamic ct angiography and was not detected prior to direction patient use.There was no serious injury/death, no blood loss, no unprotected chemo exposure, no delay in critical therapy, no adverse operator consequences, and no med/surg intervention required.The device was not changed out/replaced with no further problems encountered.There was patient involvement but no patient harm.
Event or Problem Description
Additional information received on 27-jan-2025 stating that the event occurred in dynamic ct angiography and was not detected prior to direct patient use.There was no serious injury/death, no blood loss, no unprotected chemo exposure, no delay in critical therapy, no adverse operator consequences, and no med/surg intervention required.The device was not changed out/replaced with no further problems encountered.Number of involved problematic devices is 10.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
The complaint of leakage on item ih-eh41810 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The device history lot number review couldn't be performed due to the lot number for this complaint was unknown.Additional information in b3, b5, d9, and d10.

• Brand Name: 18 CM (7") APPX 0.43 ML, PRESSURE INFUSION EXT SET W/SURPLUG¿ MICRO CLEAR, ROTAT
• 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: 21031081
• Report Number: 9617594-2024-01869
• Device Sequence Number: 19825731
• Product Code: FPA
• UDI-Device Identifier: 00887709006393
• UDI-Public: (01)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2025

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: IH-EH41810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2024
• Supplement Date Received by Manufacturer: 01/27/2025; 01/28/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/27/2025; 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INSYTE AUTOGUARD; INSYTE AUTOGUARD., MFR UNK; MEDIKIT EXTENSION TUBING; MEDIKIT EXTENSION TUBING, MFR UNK
• Patient Sex: Unknown