MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW EXTENDED DWELL PERIPHERAL CATHETER SYSTEM; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number IPN920647

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/04/2023

Event Type  Injury  

Event Description

The patient had a right forearm arrow iv placed on (b)(6) 2023 for intravenous access and iv abx administration.On (b)(6) 2023, the arrow iv was removed and it was identified that the catheter was not intact.Ultrasound was performed, which revealed a tubular lesion in the right mid forearm measuring 6 millimeters in length.The patient was taken to the operating room for removal of foreign body.

• Brand Name: ARROW EXTENDED DWELL PERIPHERAL CATHETER SYSTEM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED
• MDR Report Key: 16732953
• MDR Text Key: 313317373
• Report Number: MW5116607
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 04/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN920647
• Device Catalogue Number: EDC-00620
• Device Lot Number: 14F22L0070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American