MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; MIDLINE CATHETER

Model Number IPN037698

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  malfunction  

Event Description

During sterile placement of a dual lumen arrow midline catheter, the guidewire used to facilitate vascular access was missing from the sterile kit.This was discovered during setup and prior to access being attempted.

• Brand Name: ARROW
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 11228750
• MDR Text Key: 228621784
• Report Number: 11228750
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN037698
• Device Catalogue Number: CDC-41552-MPK1A
• Device Lot Number: 23F20J0078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1