MAUDE Adverse Event Report: SMITHS MEDICAL ITALIA SRL JELCO RADIOPAQUE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	405311
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Head Injury (1879); Pain (1994)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter pierced in several places near the plastic junction.This catheter was left in place for scalp perfusion.It caused significant infiltration of the scalp and reinstallation of catheter was done for the patient and there was scalp infiltrate/pain.There was patient involvement and patient harm reported.
Additional Manufacturer Narrative
The affected device was returned for evaluation.Visual inspection was performed, and physical damage was observed on the device.Leakage test was performed confirming the customer¿s reported problem.It is possible that the defect originated during the assembly process in the manufacturing line.No root cause was determined, and a corrective action will be recommended.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: JELCO RADIOPAQUE CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ITALIA SRL; via della stazione, 2; latina scalo ; IT
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19962273
• Report Number: 3004187702-2024-00030
• Device Sequence Number: 8867330
• Product Code: FOZ
• UDI-Device Identifier: 15019315118340
• UDI-Public: (01)15019315118340(17)260718(10)4419290
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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: 07/18/2026
• Device Catalogue Number: 405311
• Device Lot Number: 4419290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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