MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.54 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LO; STOPCOCK, I.V. SET

Catalog Number	MC33383
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: the date of event is unknown, and 01 sep 2025 has been used as a placeholder.The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A compliant was received via medwatch regarding smallbore extension set w/ microclave clear with item number mc33383 and lot number 14514265.It was reported that micropreemie with single lumen picc receiving medications and iv antibiotics through a medline.Medline clave was leaking and had fluid stuck in the clave where fluid should not be.Medications were being administered before leak was discovered.The patient involved was a 17 day old, male.There was no reported patient harm.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.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 a cause cannot be determined.The dhr was reviewed and no nonconformities were found that would have led to the reported complaint.Corrected information can be found in d10 concomitant products.

• Brand Name: 60" (152 CM) APPX 0.54 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, LUER LO
• 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: 23561801
• Report Number: 9617594-2025-02169
• Device Sequence Number: 21372486
• Product Code: FMG
• UDI-Device Identifier: 00887709038295
• UDI-Public: (01)00887709038295(17)300701(10)14514265
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: MC33383
• Device Lot Number: 14514265
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2025
• 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: PICC LINE, MEDLINE; SINGLE LUMEN PICC LINE, MFR MEDLINE; UNSPECIFIED MEDS AND IV ANTIBIOTICS, MFR UNK
• Patient Age: 17 DA
• Patient Sex: Male