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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Inserted #24g iv into the hand, beautiful flash, then catheter appeared to break and blood began oozing out of catheter as registered nurse (rn) advanced catheter.When rn attempted to obtain labs while catheter not fully advanced a "suction" sound was heard from the exposed catheter.It was then removed and observed to be bent / broken.

• 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: 19201998
• Report Number: 19201998
• Device Sequence Number: 12788903
• 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): 01/24/2024
• Report Date (Section F): 01/24/2024

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: 4266528
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Date Report Sent to FDA: 01/24/2024