MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 138" (350 CM) APPX 18.4 ML 15 DROP ADMIN SET W/3 CLAVE¿, CHECK VALVE, FLOW CONTR; STOPCOCK, I.V. SET

Model Number	B33959
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation, however has not been received.
Event or Problem Description
The event involved a 138" (350 cm) appx 18.4 ml 15 drop admin set w/3 clave¿, check valve, flow controller, 2 gang 4-way clave¿ stopcock, spin luer w/filter cap, 1 ext, drop-in ext set w/remv clave¿, spin luer w/filter cap where it was reported particulate matter was found in the set.The customer stated there was black matter that was located in the drip chamber.The event occurred when it was opened and still in the package.There was no patient involvement and no patient harm.
Additional Manufacturer Narrative
Received one used.List #b33959, 138" (350 cm) appx 18.4 ml 15 drop admin set w/3 clave¿, check valve, flow controller, 2 gang 4-way clave¿ stopcock, spin luer w/filter cap, 1 ext, drop-in ext set w/remv clave¿, spin luer w/filter cap; lot #8602283.One used.List #unknown, lactated ringer's injection 1000ml bag; lot #5376760.Burnt plastic particles were confirmed to be embedded within the cylinder walls of the drip chamber.The burnt plastic was not exposed to the fluid path.The probable cause is a molding anomaly during plastic injection molding.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to mfr on 1/5/2023.

• Brand Name: 138" (350 CM) APPX 18.4 ML 15 DROP ADMIN SET W/3 CLAVE¿, CHECK VALVE, FLOW CONTR
• 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: 16102435
• Report Number: 9617594-2023-00017
• Device Sequence Number: 7655095
• Product Code: FMG
• UDI-Device Identifier: 00887709121423
• UDI-Public: (01)00887709121423(17)270901(10)8602283
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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 Model Number: B33959
• Device Catalogue Number: B33959
• Device Lot Number: 8602283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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