MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1514
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The extension piece of a 4" smallbore ext set w/clamp, rotating luer reportedly leaked a profound amount of unspecified iv fluids.This issue was noted upon assessment after the nurse was called to the patient bedside to assess the leaking picc line.New fluids were ordered, and the entire line replaced and changed in a sterile manner per the nnicu protocol.The lot number is unknown, as this device has been in place since the picc was placed on (b)(6) 2025.No more leakage was noted since changing out the line and line and it was flushed without difficulty with the new fluids hung.There was no patient harm noted.
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.
Additional Manufacturer Narrative
Additional information: investigation summary received one (1) used b1514 smallbore ext set connected to one (1) non-icu medical trifuse set.No defects or anomalies noted.The sets were leak tested per product specifications.There was leakage from the tubing at the male luer bond pocket.Examination of the leak area showed a tear in the tubing.The reported complaint of leakage can be confirmed due to the tear.The probable cause of the tear is due to an unintentional pulling force during use.A device history review could not be conducted because no lot number(s) was/were identified.Correction: h6 - imdrf g code - investigation clarified the component code.

• Brand Name: 4" SMALLBORE EXT SET W/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: 23751431
• Report Number: 9617594-2025-02266
• Device Sequence Number: 15848863
• Product Code: FMG
• UDI-Device Identifier: 00887709002227
• UDI-Public: (01)00887709002227
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: B1514
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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 (PERIPHERALLY INSERTED CATHETER), MFR UNK.; UNSPECIFIED IV FLUIDS, MFR UNK.
• Patient Sex: Unknown