MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3" (8 CM) APPX 0.22 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿, 2 CLAMPS (BLUE; STOPCOCK, I.V. SET

Catalog Number	B33868
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint/event involved a s3" (8 cm) appx 0.22 ml, smallbore bifuse ext set w/2 microclave¿, 2 clamps (blue), rotating luer.It was reported that an unspecified chemotherapy was running through the tubing when blood was observed on the sheets from a lab draw where it was leaking out of the cap.The tubing was set up in a closed system.There were no holes, cuts, tears or any defects noted.The tubing was replaced and the infusion therapy resumed.A chemotherapy spill was cleaned up per facility control.It did not come into contact with the patient or healthcare provider.There was no adverse event/human harm associated with this complaint/event.
Additional Manufacturer Narrative
The customer's complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record was reviewed and no non-conformities were found that would have led to the reported complaint.

• Brand Name: 3" (8 CM) APPX 0.22 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE¿, 2 CLAMPS (BLUE
• 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: 19817715
• Report Number: 9617594-2024-00934
• Device Sequence Number: 8694718
• Product Code: FMG
• UDI-Device Identifier: 00887709084223
• UDI-Public: (01)00887709084223(17)280601(10)13661357
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/16/2024

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: B33868
• Device Lot Number: 13661357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMOTHERAPY, MFR UNK.
• Patient Sex: Unknown