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

Device Problems Material Frayed (1262); Difficult to Remove (1528); Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/21/2022

Event Type  Injury  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
• MDR Report Key: 15310902
• MDR Text Key: 298935769
• Report Number: MW5111742
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 20801902117223
• UDI-Public: 20801902117223
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White