MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 100" (254 CM) APPX 12.6 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B9201
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation- the investigation is pending.
Event or Problem Description
The event involved a 100" (254 cm) appx 12.6 ml, 15 drop primary set w/2 microclave®, rotating luer where it was reported that at 4:30 pm during a round, they observed liquid on the infusion pump but only one bag of nacl 0.9 with a gravity tubing is hung.From the valve to the drip chamber, the tubing is damp, so the leak is hardly visible.There were patient involvement and no reported harm however consequences only risk of infection in the patient neutropenia and loss of sterility.
Additional Manufacturer Narrative
A photo was returned showing the packaging information.Also, one used primary set was received for inspection.No defects or anomalies noted.The set and mating device was leak tested per product specifications.There was no leakage.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: 100" (254 CM) APPX 12.6 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, ROTATING LUER
• 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: 23317088
• Report Number: 9617594-2025-02005
• Device Sequence Number: 12212813
• Product Code: FMG
• UDI-Device Identifier: 00887709013155
• UDI-Public: (01)00887709013155(17)280101(10)14240091
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: B9201
• Device Lot Number: 14240091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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: NACL 0.9, MFR UNK.; UNSPECIFIED INFUSION PUMP, MFR UNK.
• Patient Sex: Unknown