MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 16.5 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, REMV 2 GANG 4-W; STOPCOCK, I.V. SET

Catalog Number	B90019
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.E1 additional initial reporter phone number: (b)(6).
Event or Problem Description
The event occurred on an unspecified date and involved a 128" (325 cm) appx 16.6 ml, 15 drop primary set w/2 microclave¿, remv 2 gang 4-way clave¿ stopcock, rotating luer, 2 ext where it was reported a registered nurse primed the set and the fluid could be seen at the end of the tubing and in the distal chamber.When the device was connected to the patient's iv, blood backed out into the tubing and would not run.The customer stated the iv flushed great at the closest port to the patient.It would not flow to gravity.They had to remove the tubing and place a new set up which worked for the case.There was patient involvement, however no patient harm reported.
Additional Manufacturer Narrative
Received: one (1) used.List #b90019, 128" (325 cm) appx 16.6 ml, 15 drop primary set w/2 microclave¿, remv 2 gang 4-way clave¿ stopcock, rotating luer, 2 ext; lot #13598628.The reported complaint of back flow and no flow at gravity was not confirmed.No visual anomalies were observed on the returned set.The check valve resistance of the sample was tested, according to customer drawing specification from the distal end, to test the check valve, and no backflow was confirmed after the test.The set was primed to gravity pressure and a normal flow was observed through the device.No occlusion or anomalies were observed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 128" (325 CM) APPX 16.5 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, REMV 2 GANG 4-W
• 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: 18654681
• Report Number: 9617594-2024-00103
• Device Sequence Number: 7084265
• Product Code: FMG
• UDI-Device Identifier: 00887709011694
• UDI-Public: (01)00887709011694(17)280301(10)13598628
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: B90019
• Device Lot Number: 13598628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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