MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 15.4 ML, 10 DROP ADMIN SET W/0.2 MICRON FILTER, CLAVE®, ROTAT; STOPCOCK, I.V. SET

Catalog Number	B9650
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product samples, videos, or photographs were provided for investigation.The lot history was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.Additional contact: (b)(4).(b)(6).
Event or Problem Description
The product involved is a 102" (259 cm) appx 15.4 ml, 10 drop admin set w/0.2 micron filter, clave¿, rotating luer, and the event date is unknown.As per the report, there was a leak at the catheter hook up.There was no hole, cut or tear or any defect that the customer could see.The incident happened after connecting the patient and starting the iv line.The customer disconnected the patient and started a new line.There was patient involvement but no patient harm.

• Brand Name: 102" (259 CM) APPX 15.4 ML, 10 DROP ADMIN SET W/0.2 MICRON FILTER, CLAVE®, ROTAT
• 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: 18312440
• Report Number: 9617594-2023-01130
• Device Sequence Number: 6783915
• Product Code: FMG
• UDI-Device Identifier: 00887709014763
• UDI-Public: (01)00887709014763(17)270801(10)8359976
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2023

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: B9650
• Device Lot Number: 8359976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MYERS COCKTAIL, MFR UNK; NAD IN NORMAL SALINE, MFR UNK
• Patient Sex: Unknown