MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B2020
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 60" (152 cm) appx 0.4ml, smallbore ext set w/clamp, luer lock was found to have experienced a leak during patient use.It was reported that that fluid was dripping to the floor by the intravenous (iv) pole.Upon investigation, morphine was found to be leaking from the tubing where the smartsite connects to the tubing.Additionally, there was a crack in the tubing.It was also mentioned that the patient had abnormal vitals (temperature/hr, rr), work of breathing, and agitation emesis.No additional information was reported.
Additional Manufacturer Narrative
One (1) used.List #b2020, 60" (152 cm) appx 0.4ml, smallbore ext set w/clamp, luer lock; lot #14080229.One (1) used.List #unknown, microclave; lot #unknown.A crack was observed on the female luer.One (1) new.List #b2020, 60" (152 cm) appx 0.4ml, smallbore ext set w/clamp, luer lock; lot #14080229.No visual damages or anomalies were observed on the new set.The reported complaint of a crack could be confirmed.The returned extension set was observed to have a crack on the female luer.The probable cause is due to a material issue on a vendor-supplied part.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 60" (152 CM) APPX 0.4ML, SMALLBORE 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: 22341202
• Report Number: 9617594-2025-01356
• Device Sequence Number: 15729447
• Product Code: FMG
• UDI-Device Identifier: 00887709002937
• UDI-Public: (01)00887709002937(17)290701(10)14080229
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: B2020
• Device Lot Number: 14080229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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: MORPHINE, UNK MFR.
• Patient Sex: Unknown