MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	308300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
24 g iv placed in patient's hand when flushed a hole in the catheter was found when blood shot out.

• Brand Name: JELCO
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 19593557
• Report Number: 19593557
• Device Sequence Number: 3980833
• Product Code: FOZ
• UDI-Device Identifier: 30351688071365
• UDI-Public: (01)30351688071365
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/18/2024
• Report Date (Section F): 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 Model Number: 308300
• Device Lot Number: 4331965
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 17 MO
• Patient Sex: Female
• Patient Weight: 12 KG
• Date Report Sent to FDA: 03/18/2024