MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 34" EXT SET W/CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B1549
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The event involved a 34" ext set w/clamp, luer lock where it was reported that patient was more awake on sedation and pillow was wet under arm.No visible leaking from iv sites, went to reposition the patient in bed and blood started to backflow through an iv and out onto the floor through a hole in the patient's iv line.It was an extension tubing set, clamped the line and disconnected the faulty setup.A new bag and line of precedex set up and connected.There was patient involvement, but no patient harm reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.No lot number was provided.A device history lot number review cannot be performed.D4: only di provided as lot number is unknown.Additional reporter: (b)(6).

• Brand Name: 34" EXT SET W/CLAMP, LUER LOCK
• 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: 22057268
• Report Number: 9617594-2025-01064
• Device Sequence Number: 15406922
• Product Code: FMG
• UDI-Device Identifier: 00887709002555
• UDI-Public: 00887709002555
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: B1549
• 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: 04/22/2025
• Initial Report FDA Received Date: 05/20/2025
• 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: PRECEDEX, UNK MFR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown