MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	46100-91
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a cath lab w/5 port "off" manifold (600 psi), 72" admin set and 4 ft transpac® iv where the customer reported that they had issues with the connection of the transducer on the left to the manifold; transducer on the left was cracked causing fluid to spray or flow out.The transducers were not connected to other device when the incident happened.The device was flushed with heparinized saline.There was unknown patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.A manufacturing record review could not be completed as the lot number was not provided by the customer.A device history record review could not be conducted because no lot number was provided.

• Brand Name: CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 19504886
• Report Number: 9617594-2024-00747
• Device Sequence Number: 3982137
• Product Code: DQO
• UDI-Device Identifier: 00840619070601
• UDI-Public: (01)00840619070601
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K932141
• 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): 01/14/2025

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: 46100-91
• Device Lot Number: UNKNOWN
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 01/14/2025
• 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: HEPARIN SALINE, MFR UNK
• Patient Sex: Unknown