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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although multiple attempts were made to obtain the device, it is not available for investigation at this time.A review of the device history record is pending.
Event or Problem Description
Leakage of an unspecified fluid/infusate was reported at the hub site of a 7" (18 cm) appx 0.31 ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, rotating luer directly after staff started the patient's iv.They attempted to take the j-loop tubing off and the top part of it broke off.Although they eventually got the j-loop off the patient, they almost had to start another iv.When attempting to trouble shoot the leakage, the product broke.There was an unspecified delay of treatment for the patient while the user attempted to identify and rectify the leak.There were no negative effects or harm to the patient due to the delay.No further information is available at this time.
Additional Manufacturer Narrative
No device was received for investigation.Therefore, the reported complaint is unable to be confirmed.If the device is received, the investigation will be re-opened for further evaluations.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Additional Manufacturer Narrative
Corrected information can be found in e4 - initial report sent to fda and h7 - if remedial action initiated null.(b)(4) in h10 was entered in error and should be disregarded.

• 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: 24644039
• Report Number: 9617594-2026-00288
• Device Sequence Number: 18615707
• Product Code: FPA
• UDI-Device Identifier: 00887709037519
• UDI-Public: (01)00887709037519(17)290901(10)14134935
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2026

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: 14134935
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 03/24/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/16/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: J-LOOP TUBING DEVICE, MFR UNK; UNSPECIFIED FLUID/INFUSATE, MFR UNK
• Patient Sex: Unknown