MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 4.6 ML, EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LU; STOPCOCK, I.V. SET

Catalog Number	B9061
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint on the b9061 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 report (dhr) for lot 13909381 was reviewed and no non conformities were found that would have led to the reported complaint.
Event or Problem Description
It was reported that a 14" (36 cm) appx 4.6 ml, ext set w/clave®, 0.2 micron filter, clamp, rotating luer was found to be occluded during patient use.The reporter stated that the filter on the irinotecan and leucovorin infusion lines could not infuse.There was no patient harm reported.
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.

• Brand Name: 14" (36 CM) APPX 4.6 ML, EXT SET W/CLAVE®, 0.2 MICRON FILTER, CLAMP, ROTATING LU
• 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: 20447742
• Report Number: 9617594-2024-01448
• Device Sequence Number: 7026687
• Product Code: FMG
• UDI-Device Identifier: 00840619045821
• UDI-Public: (01)00840619045821(17)290201(10)13909381
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/17/2024

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: B9061
• Device Lot Number: 13909381
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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: IRINOTECAN, UNK MFR; LEUCOVORIN, UNK MFR
• Patient Sex: Unknown