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 two of two.

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.

• 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: 18634007
• MDR Text Key: 334786276
• Report Number: 9617594-2024-00085
• 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

• 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?: No
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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