MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH; STOPCOCK, I.V. SET

Catalog Number	A1141
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation, however, it has not yet been received.D4: only di provided as lot number is unknown.
Event or Problem Description
An event involving a smallbore trifuse ext set with 3 microclave reported that the registered nurse (rn) was attempting to attach syringe to intravenous (iv) tubing to flush the peripherally inserted central catheter (picc) when the iv tubing cracked.Later, the rn clamped picc in 2 places and disconnected cracked iv tubing from the lumen of the picc.Rn checked patency of picc lumen by flushing and drawing back to check blood return.The medications need to be restarted upon receiving from pharmacy.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
D9 - date returned to mfr: 3/24/2026.Received one (1) used a1141 smallbore trifuse ext set w/3 microclave for inspection.The nanoclave y-connector was broken apart.Examination of the break showed cold form damage.The reported complaint can be confirmed.The probable cause is due to an unintentional bending force during use.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.

• Brand Name: 9.5" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® CLEAR,NANOCLAVE® (RED RING), 3 CH
• 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: 24301799
• Report Number: 9617594-2026-00107
• Device Sequence Number: 21247890
• Product Code: FMG
• UDI-Device Identifier: 00887709069343
• UDI-Public: 00887709069343
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: A1141
• Device Lot Number: UNKNOWN
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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, UNK MFR.
• Patient Sex: Unknown