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	07/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - (b)(6).The device has been received for evaluation, however, investigation is not yet complete.
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 the customer reported leaking, at the red knob, during patient infusion of a critical drug inotropes that came into contact with the patient and healthcare provider.There was patient involvement, but no harm was reported as a consequence of this event; there was work flow disruption and a spill kit was not used.
Additional Manufacturer Narrative
Received one (1) used b5505 ext set w/4 gang 1o2® manifold w/baseplate (blue, green, yellow, red) for inspection.No defects or anomalies were noted.Each valve was connected to a 36" head height fluid reservoir from the side port, primed, and left for 24 hours.There was leakage from the white button from the yellow button port.The reported complaint can be confirmed.The probable cause is related to a molding defect in the white button molded component used in the 1o2 smart valve.A device history review (dhr) 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19931623
• Report Number: 9617594-2024-01085
• Device Sequence Number: 12797169
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 07/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: INOTROPES, MFR UNK; MICROCLAVE, ICU
• Patient Sex: Unknown