MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) ARROW CENTRAL VENOUS CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	IPN036482
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
While placing a right femoral mml, dr.(b)(6) was removing the guidewire, dr.(b)(6) stated that she felt that the line ¿broke¿.She removed the mml, and guidewire and it was discovered that the guidewire was frayed and partially came apart, potentially becoming catastrophic to the patient.Dr.(b)(6) decided to discontinue the line insertion.Dr.(b)(6) held pressure over the insertion site to stop the bleeding.Dr.(b)(6) then decided to place a different mml at a different site.The guidewire and packaging for the mml was saved for further investigation.

• Brand Name: ARROW CENTRAL VENOUS CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
• MDR Report Key: 15310902
• Report Number: MW5111742
• Device Sequence Number: 5467018
• Product Code: FOZ
• UDI-Device Identifier: 20801902117223
• UDI-Public: 20801902117223
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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: 09/30/2023
• Device Model Number: IPN036482
• Device Catalogue Number: CDC-45703-XPB1A
• Device Lot Number: 13F22A0732
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White