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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a 60" (152 cm) appx 0.4ml, smallbore ext set w/clamp, luer lock that experienced leakage during patient use.It was reported that there is a crack in the tubing causing it to leak when administering medication at the smartsite connection.The medication that was leaking at the time of the event was sedation drug.There was patient involvement.There was no adverse event.
Additional Manufacturer Narrative
Received one (1) used b2020 smallbore ext set for inspection.A crack was observed on the female luer.The reported complaint of leakage can be confirmed due to the crack found.The probable cause is due to a material issue with 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: 21989265
• Report Number: 9617594-2025-00947
• Device Sequence Number: 18218290
• Product Code: FMG
• UDI-Device Identifier: 00887709002937
• UDI-Public: (01)00887709002937(17)291201(10)14238039
• 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,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 14238039
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: UNSPECIFIED SEDATION DRUG, MFR UNKNOWN.
• Patient Sex: Unknown