MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC9013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation; however, a lot number was provided.A device history lot number review is pending.B3: 11/1/2025 added as placeholder due to event occurring on an unspecified date in november 2025.
Event or Problem Description
The event occurred on an unspecified date in (b)(6) 2025 and involved a 14" ext set w/0.2 micron filter, clave® clear, clamp, rotating luer.It was reported that liquid was on the floor, and a leak of chemotherapy was noticed along the primary tubing, at the filter area.The spill ran under and behind the chair where patient was sitting.None of the chemotherapy leaked on to the patient.Infusion was stopped, patient disconnected and moved to another area.Spill <500ml was cleaned by pharmacy per protocol.Patient eventually restarted with another bag of chemo.Event occurred at an outpatient treatment facility.There was patient involvement, but no harm reported.
Additional Manufacturer Narrative
Complaint of leaks on item mc9013 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 report (dhr) lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, 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: 24088713
• Report Number: 9617594-2026-00028
• Device Sequence Number: 20303196
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: (01)00887709039391(17)300801(10)14528482
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: MC9013
• Device Lot Number: 14528482
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2025
• 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: PRIMARY PLUM SET 146870489 LOT# 14481964 ICU MED; UNSPECIFIED CHEMOTHERAPY, UNK MFR
• Patient Age: 54 YR
• Patient Sex: Unknown