MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 72" SMALLBORE EXT SET W/CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B2033
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation; however, a lot history review should be conducted.
Event or Problem Description
The event occurred on an unspecified date and involved a 72" smallbore ext set w/clamp, luer lock where the customer reported that the product will not allow fluid to flow.Patient involvement was not reported; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Additional information can be found in b5 describe event or problem.Corrected information can be found in b3 - date of event, e3 - initial reporter occupation, e4 - initial report sent to fda and h6 component code.
Event or Problem Description
Additional information was received from the customer on 01mar2026 stating that the product would not allow flow when attempting to administer a bolus dose of unspecified medication for a patient.There was no human harm.
Additional Manufacturer Narrative
Received one (1) used b2033 smallbore ext set w/clamp for inspection.No defects or anomalies noted.The b2033 smallbore ext set was primed.There were no occlusions and restrictions in flow.The reported complaint was unable to be replicated or confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 72" SMALLBORE EXT SET W/CLAMP, LUER LOCK
• Common Device Name: STOPCOCK, I.V. SET
• 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: 24501468
• Report Number: 9617594-2026-00219
• Device Sequence Number: 21481109
• Product Code: FMG
• UDI-Device Identifier: 00887709002975
• UDI-Public: (01)00887709002975(17)271101(10)12160774
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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: B2033
• Device Lot Number: 12160774
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/01/2026; 04/21/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/17/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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: UNSPECIFIED MEDICATION, MFR UNK.
• Patient Sex: Unknown