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	12/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
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 a set was leaking and connections were not secure.The customer further stated that the products were cracked, and fluid sprayed out the side of the connection to transducer when connected to pressure and fluid.There was patient involvement but no harm was reported as a consequence of this event.This is report one of two.
Additional Manufacturer Narrative
The reported complaint of a leak and connections would not secure was confirmed.During visual inspection, cracks and crazing near the cracks was observed on the female luer on both ends of the manifold.The returned set was primed and pressure leak tested and leaks were observed from the crack of the female luer on both ends of the manifold.The probable cause of the crack and crazing around the crack had occurred due to environmental stress cracking during use.The dhr for lot number 13672865 was reviewed and there were no relevant non-conformances found.

• 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: 18632865
• Report Number: 9617594-2024-00081
• Device Sequence Number: 7889057
• Product Code: DQO
• UDI-Device Identifier: 00840619070601
• UDI-Public: (01)00840619070601(17)260601(10)13672865
• 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): 03/01/2024

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 Expiration Date: 06/01/2026
• Device Catalogue Number: 46100-91
• Device Lot Number: 13672865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown