MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXT SET 7IN CLV SL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 126600490

Device Problem Material Rupture (1546)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

The event involved an ext set 7in clv sl where it was reported that the tubing burst during contrast injection in ct scan.These loops were used for high pressure injection.The product was connected to patient and ct injector was connected to luer lock port.Due to the event the scans had poor images due to insufficient contrast.There was patient involvement and no patient harm.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Manufacturer Narrative

Received one used 146870489 primary plum set for inspection.As received, the tubing on set was ruptured and flared.This type of tubing damage is consistent with a high pressure injection during use.The dfu states: caution: not for high pressure infusion.The reported complaint can be confirmed.The probable cause is due to a high pressure injection on a device that is not rated for high pressure during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

Event Description

Two devices were returned for evaluation.This captures the first of two devices returned.

• Brand Name: EXT SET 7IN CLV SL
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18572314
• MDR Text Key: 334740624
• Report Number: 9615050-2024-00068
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005612
• UDI-Public: (01)10887787005612(17)260701(10)13639925
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151969
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 126600490
• Device Lot Number: 13639925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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
• Treatment: CONTRAST INJECTOR, UNK MFR; CONTRAST, UNK MFR