MAUDE Adverse Event Report: COOK MEDICAL/COOK, INC. CENTRAL VENOUS CATHETER TRAY; CATHETER, PERCUTANEOUS

Model Number	C-PMSY-501J
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Foreign Body In Patient (2687)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 the patient had several lines placed, including two arterial lines in her bilateral groins.On (b)(6) 2022 at 0815 the patient's rn noted that the left femoral arterial line was bleeding.As the dressing was changed the rn discovered that the catheter of the arterial line had broken off and a portion remained in the patient's leg.Physicians used ultrasound to identify that a 13cm piece of the broken catheter was in the patient's groin.The patient was taken emergently to the or (operating room) for surgical removal of the broken catheter.The removal was completed without surgical complications and the patient has been cleared from a surgery standpoint.Fda safety report id #(b)(4).

• Brand Name: CENTRAL VENOUS CATHETER TRAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK MEDICAL/COOK, INC.; bloomington IN 47404
• MDR Report Key: 15916605
• Report Number: MW5113627
• Device Sequence Number: 2468763
• Product Code: DQY
• UDI-Device Identifier: 00827002020672
• UDI-Public: (01)00827002020672(17)240801(10)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: C-PMSY-501J
• Device Catalogue Number: C-PMSY-501J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White