MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" SMALLBORE EXT SET W/CLAVE®, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B9438
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is discarded and is not available for investigation.Without the return of the device a probable root cause is unable to be determined.A device history review could not be completed due to the unknown lot number.D4: only di provided as lot number is unknown.
Event or Problem Description
The event involved an 8" smallbore ext set w/clave®, clamp, rotating luer and it was reported that the catheter or tubing cracked/damaged/severed.It was found with intravenous (iv) tubing severed 1-2inches above t-connector.The line was open and blood was leaking.The line was removed immediately and appropriate care completed and the catheter remained intact.The medication used were flumazenil, ondansetron, dexmedetomidine, dexamethasone, ketorolac, propofol, and remifentanil.There was patient involvement and no reported patient harm/ injury.
Additional Manufacturer Narrative
A photo was returned showing a small amount of red fluid at the insertion of the tubing into the y-clave bond pocket.The reported complaint of a small tear in the location can be confirmed.The probable cause is unknown.The device history review (dhr) could not be reviewed due to the unknown lot number.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a root cause cannot be determined.

• Brand Name: 8" SMALLBORE EXT SET W/CLAVE®, 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: 23566303
• Report Number: 9617594-2025-02173
• Device Sequence Number: 10272954
• Product Code: FMG
• UDI-Device Identifier: 00887709013889
• UDI-Public: 00887709013889
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2025

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: B9438
• Device Lot Number: UNKNOWN
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/24/2025
• 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: DEXAMETHASONE UNK MFR.; DEXMEDETOMIDINE UNK MFR.; FLUMAZENIL UNK MFR.; KETOROLAC UNK MFR.; ONDANSETRON UNK MFR.; PROPOFOL UNK MFR.; REMIFENTANIL UNK MFR.
• Patient Sex: Unknown