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 Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding an 8" smallbore ext set w/clave®, clamp, rotating luer where they stated that "tubing was twisted and when assessing iv, the t connector had fallen apart near the blue hub.Iv remained in place as well as blue t connector piece but main line pulled out.Iv was able to save but needed to change the t connector." this event occurred during patient use.They also stated that "the device was used for 2days and the medications used were d5ns running via iv and cefazolin iv given as an antibiotic.The product was not reprocessed or re-sterilized prior to use." there was patient involvement, unknown adverse event and no delay in therapy as a result of this event.
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.
Additional Manufacturer Narrative
One used device was received for evaluation; the tubing was observed to be separated from the y-clave.The reported complaint of disconnection could be confirmed.The returned sample was observed to have the tubing separated from the y-clave.The probable cause of the disconnection is from insufficient solvent coverage during assembly in manufacturing.Lot history review could not be conducted because no lot number(s) was/were identified.

• 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: 22896939
• Report Number: 9617594-2025-01748
• Device Sequence Number: 17593144
• 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): 10/09/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 5% DEXTROSE IN NORMAL SALINE. MFR-BAXTER.; CEFAZOLIN, MFR UNKNOWN.
• Patient Sex: Unknown