MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" (30 CM) APPX 2.4 ML, EXT SET W/MICROCLAVE¿, CHECK VALVE; STOPCOCK, I.V. SET

Catalog Number	CH3557
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for investigation.Investigation pending.
Event or Problem Description
The event involved a 12" (30 cm) appx 2.4 ml, ext set w/microclave¿, check valve where it was reported that manufacturing associates performed sample collection per workflow.While performing sample collection they noticed a leak was coming from the base of the check valve of the sampling system closed plastic sterile 2.2ml, (oracle#: 108651, internal lot#:sm0705328, supplier lot#:5943362) which is welded onto the bioreactor bag as a sample port.A hemostat was immediately placed on the line close to the cell bag and the sampling port clamp was closed.There was unknown patient involvement and unknown patient harm.
Additional Manufacturer Narrative
A couple of photos were shared by customer, where is observed 2 different tears in the tube at the base of the check valve, the icu medical device is connected to an unknown set and not additional damage are observed.One used sample was received for evaluation connected to an unknown, sartorius bag.As received it was confirmed two different tears in the tube at the base of the check valve (white side).Due to the check valve flow direction and the sartorius bag connection, it was not possible to do it leak test at the device.Complaint of leaks can be confirmed based in the physical sample evaluation.Based in the tear this would be as a leak results.The probable cause of how, where and when this conditions happened it's unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 12" (30 CM) APPX 2.4 ML, EXT SET W/MICROCLAVE¿, CHECK VALVE
• 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: 17401053
• Report Number: 9617594-2023-00441
• Device Sequence Number: 6054694
• Product Code: FMG
• UDI-Device Identifier: 00887709076389
• UDI-Public: (01)00887709076389(17)270401(10)5943362
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: CH3557
• Device Lot Number: 5943362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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: BIOREACTOR BAG, UNK MFR
• Patient Sex: Unknown