MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK; STOPCOCK, I.V. SET

Catalog Number	B55005
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporting become aware date has been corrected from 5/20/2024 to 5/15/2024.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.E1 initial reporter phone number: (b)(6).
Event or Problem Description
The event involved a 14" (36 cm) ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red), check valve, clamp, rotating luer, 1 ext where it was reported that the blood backed up into the manifold and started to leak from the green port.When the line was flushed to the patient, there was no leaking of any of the ports.The continuous infusion was changed to a different port and there were no further issues.There was patient involvement however, no patient harm and no delay in therapy.
Additional Manufacturer Narrative
The reporting become aware date has been corrected from 5/15/2024 to 5/20/2024.D4: only di provided as lot number is unknown.
Additional Manufacturer Narrative
Received three used b55005 extension set w/4 gang 1o2 manifold w/baseplate for inspection.One of the returned samples had fluid residuals outside of the fluid path at the green port female luer.No mating devices were returned for inspection.The returned used b55005 was functionally tested and met product performance expectations without leaking past the side port valves.The reported complaint can be confirmed based on the fluid residuals observed.The probable cause is unknown.A device history lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 14" EXT SET W/4 GANG 1O2® MANIFOLD W/BASEPLATE (BLUE, GREEN, YELLOW, RED), CHECK
• 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: 19547183
• Report Number: 9617594-2024-00775
• Device Sequence Number: 4811688
• Product Code: FMG
• UDI-Device Identifier: 00887709010079
• UDI-Public: 00887709010079
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/20/2024

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: B55005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 05/15/2024; 05/20/2024; 06/20/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 06/19/2024; 07/19/2024; 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 FLUSH, UNK MFR.
• Patient Sex: Unknown