MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATI; STOPCOCK, I.V. SET

Model Number	B9259
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred around 10:00 am and involved a 17" (43 cm) appx 5ml non-dehp ext set w/clave®, 0.2 micron filter, clamp, rotating luer.It was reported that during the induction of the patient there was a presence of air bubbles despite an air vacuum made rigorously to 2 inhales.The inhalo clamped the intravenous tubing as soon as they saw the air bubbles pass through the filter so the patient did not get any air.After the inhalo clamped the tubing they took an empty 10ml syringe and removed about 4ml of air, until there was a return of liquid without an air bubble.Once all the air bubbles were removed, the air bubbles no longer passed through the filter.There was patient involvement, however no report of patient harm.This captures the first of five events.
Additional Manufacturer Narrative
The device has been discarded, however a sister sample is available for investigation but has not been received.Initial reporter facility name: (b)(6).
Additional Manufacturer Narrative
Received one new.List #b9259, 17" (43 cm) appx 5.0ml, ext set w/clave®, 0.2 micron filter, clamp, rotating luer; lot #5189886.Each set was primed and leak tested per product specification.No leaks observed.No air bubbles noted after the entirety of the set was primed.The complaint of air in line could not be confirmed or replicated.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information: d9- device returned to manufacturing 5/4/2022.

• Brand Name: 17" (43 CM) APPX 5ML NON-DEHP EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATI
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14191184
• Report Number: 9617594-2022-00090
• Device Sequence Number: 19928267
• Product Code: FMG
• UDI-Device Identifier: 00887709013292
• UDI-Public: (01)00887709013292(17)260201(10)5189886
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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 Expiration Date: 02/01/2026
• Device Model Number: B9259
• Device Catalogue Number: B9259
• Device Lot Number: 5189886
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/24/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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