MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Purpl; Set, Administration, Intravascular

Catalog Number	B1754
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A reported incident involving a 6.5 (17 cm) appx 0.30 ml, smallbore pressure infusion (400psig) ext set w purple clamp, rotating luer.It was reported that difficulties connecting the extension to the peripheral intravenous (piv) and intermittent leakage.Three nurses reportedly experienced connection difficulties on a couple of occasions each over approximately a two-week period.On at least two occasions, a very small amount of iv fluid reportedly leaked into the piv dressing.There was no reported patient involvement or harm.
Additional Manufacturer Narrative
The suspect product was not returned for evaluation.No product samples, pictures, or videos were received for investigation.Therefore, the complaint of leaks could not be confirmed.Without the return of the used sample or supporting evidence, a comprehensive failure investigation could not be performed, and the probable cause could not be determined.A device history review could not be completed due to the unknown lot number.

• Brand Name: 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Purpl
• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50735804
• Report Number: 9617594-2026-01252
• Device Sequence Number: 10633660
• Product Code: FPA
• UDI-Device Identifier: 00887709082410
• UDI-Public: (01)00887709082410
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: B1754
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/11/2026
• 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: 24 g BD Insyte Autogard Winged
• Patient Sex: Male
• Patient Race: Black Or African American