MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number	B1434
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received with regards to a 8" (20cm) smallbore ext set w/0.2 micron filter, clamp, rotating luer that experienced breakage and leakage.The reporter stated that leaking fluids, crack at connection point.Tubing was changed.Occurred while in use with patient.No injury, harm or death reported.Complaint quantity is one.Sample was decontaminated.The event date was on 12-oct-2024.The status of the product at the time of event was during use on a patient.There was no adverse event and no injury or death.
Additional Manufacturer Narrative
Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Investigation summary: received one (1) used b14341 smallbore ext set connected to one (1) used list#: unknown extension tubing for inspection.As received, an axial crack was observed along the length of the female luer of the b1434.The set was leak tested per product specifications.There was leakage from the crack.The reported complaint of leakage can be confirmed due to the crack.The probable cause of the crack is due to environmental stress cracking during use.The lot history was reviewed, no nonconformities were identified that may contributed to the reported complaint.

• Brand Name: 8" (20 CM) APPX 0.49 ML, SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAMP, ROTATING
• 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: 20754156
• Report Number: 9617594-2024-01653
• Device Sequence Number: 20938128
• Product Code: FMG
• UDI-Device Identifier: 00887709001657
• UDI-Public: (01)00887709001657(17)281201(10)13856047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: B1434
• Device Lot Number: 13856047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/30/2025
• 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
• Patient Sex: Unknown