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

Model Number 20G, 6CM ENDURANCE EXTENDED DWEL

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2023

Event Type  Injury  

Event Description

An extended dwell catheter fractured at the hub with the line still in a patient's arm, unknown how the breakage occurred.This was found when a nurse went to flush the catheter and saline pooled under the dressing.After pulling back the dressing, she found the catheter protruding from the patient's arm and were able to remove it.The catheter is a 20g, 6cm endurance extended dwell catheter with a lot # of 14f22k0210.A similar incident was reported on may 23, 2022 for the same product, also a 20g, 6cm, with a lot # of 14f22c0098.In that case the patient had a line fracture and the catheter migrated into his left upper arm and the patient had to go to interventional radiology to have the object retrieved from his vessel.At that time a patient safety report was entered and the manufacturer conducted a series of tests on the device and was unable to determine why the fracture occurred.Reference report: mw5114835.

• Brand Name: ENDURANCE EXTENDED DWELL 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: 16350883
• MDR Text Key: 309368094
• Report Number: MW5114834
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20G, 6CM ENDURANCE EXTENDED DWEL
• Device Catalogue Number: EDC-00620
• Device Lot Number: 14F22K0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• 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