MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41" (104 CM) APPX 4.7 ML, 15 DROP ADMIN SET WITH BAG HANGER, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B3065
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	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information: the date this complaint issue was observed by the reporter was not provided with the original complaint.The date of the event is unspecified.
Additional Manufacturer Narrative
A photo was received from the customer showing an object in the drip chamber.The following was received for complaint investigation: -one used list #b3065, 41" (104 cm) appx 4.7 ml, 15 drop admin set with bag hanger, rotating luer; lot #13672495.One used list #unknown, 0.9% sodium chloride; lot #v24i13a burnt plastic material was observed on the drip chamber.Particulate on the drip chamber could be confirmed.A black particulate was found embedded in the drip chamber and was measured.The particulate was found to be within specification and is a passable condition.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in b5 d9 e3 and h6 component code.
Event or Problem Description
A complaint was received regarding a 41" (104 cm) appx 4.7 ml, 15 drop admin set with bag hanger, rotating luer that experienced particulate matter.The report stated that while priming a staff member noticed a couple of particles/contaminants within the drop chamber of the tubing set.This was immediately set aside and internal procedures started with quarantining the lot while further investigation and guidance is received.There was no patient involvement and no patient harm.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.

• Brand Name: 41" (104 CM) APPX 4.7 ML, 15 DROP ADMIN SET WITH BAG HANGER, ROTATING LUER
• 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: 21668872
• Report Number: 9617594-2025-00532
• Device Sequence Number: 14565571
• Product Code: FMG
• UDI-Device Identifier: 00840619045562
• UDI-Public: (01)00840619045562(17)280601(10)13672495
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: B3065
• Device Lot Number: 13672495
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2023
• 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