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

Catalog Number	126600490
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional 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 or Problem Description
Two devices were returned for evaluation.This captures the first of two devices returned.

• Brand Name: EXT SET 7IN CLV SL
• Common Device Name: 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
• Report Number: 9615050-2024-00068
• Device Sequence Number: 7140396
• Product Code: FPA
• UDI-Device Identifier: 10887787005612
• UDI-Public: (01)10887787005612(17)260701(10)13639925
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151969
• 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): 03/18/2024

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: 07/01/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONTRAST INJECTOR, UNK MFR; CONTRAST, UNK MFR
• Patient Sex: Unknown