MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CATH LAB KIT FOR INDUSTRIAL DRUG SUPPLIES, USA; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	011-0J553-01
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01jul2025 has been used as a placeholder.D4, g4: model number is not sold in the us but similar device is sold under model 46100-83.This product was used for the di, product code, and 501k.The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a cath lab kit for industrial drug supplies, usa, that experienced air in line during infusion.The reporter stated that they have faulty manifold/syringes introducing air in the system.The problem occurred during infusion during injecting coronaries.The type of procedure was cardiac catheterization.The issue was not detected prior to direct patient use.The length of time the product was in use was 30 minutes.There was no serious injury/death nor blood loss.No chemo leak nor unprotected chemo exposure.No medical/surgical intervention required.The device(s) was changed out/replaced with no further problems encountered.
Additional Manufacturer Narrative
Investigation summary the complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history could not be reviewed due to the unknown lot number.

• Brand Name: CATH LAB KIT FOR INDUSTRIAL DRUG SUPPLIES, USA
• 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: 22800233
• Report Number: 9617594-2025-01674
• Device Sequence Number: 12954640
• Product Code: DQO
• UDI-Device Identifier: 00840619069162
• UDI-Public: 00840619069162
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: 02/01/2026
• Device Catalogue Number: 011-0J553-01
• Device Lot Number: 13539841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• 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