MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM)APPX 15.3ML 20 DROP ADMIN W/MICROCLAVE®, 0.2 MICRON FILTER, FLOW CO; STOPCOCK, I.V. SET

Model Number	B9837
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is pending investigation.
Event or Problem Description
The customer reported that a 102" (259 cm)appx 15.3ml 20 drop admin w/microclave®, 0.2 micron filter, flow controller, rotating luer was defective.It was further described that the dial-a-flow isn¿t working correctly and the flow rate is too fast.There was patient involvement but there was no harm or delay in therapy.
Additional Manufacturer Narrative
One used 102" (259 cm)appx 15.3ml 20 drop admin w/microclave¿, 0.2 micron filter, flow controller, rotating luer was received and visually inspected.As received, no visible damage or anomalies were observed.No mating devices were returned.The set was primed while the flow regulator was in the open position.Unrestricted flow was established.A flow controller test was conducted and the product met performance specifications.The reported complaint could not be confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 102" (259 CM)APPX 15.3ML 20 DROP ADMIN W/MICROCLAVE®, 0.2 MICRON FILTER, FLOW CO
• 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: 13170407
• Report Number: 9617594-2022-00001
• Device Sequence Number: 1689419
• Product Code: FMG
• UDI-Device Identifier: 00887709015890
• UDI-Public: (01)00887709015890(17)260901(10)5607492
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: 09/01/2026
• Device Model Number: B9837
• Device Catalogue Number: B9837
• Device Lot Number: 5607492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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