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

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation, however, investigation is not yet complete.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 334847984
• Report Number: 9617594-2024-00081
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00840619070601
• UDI-Public: (01)00840619070601(17)260601(10)13672865
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1