MAUDE Adverse Event Report: ARROW MULTI-LUMEN CVC KIT

Model Number REF ASK-45703-PGM1

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/05/2019

Event Type  Injury  

Event Description

Pt presented to ed in diabetic ketoacidosis requiring a central line placed due to poor peripheral vein access, post insertion chest x-ray showed, a piece of retained guidewire.Vascular surgery consulted, pt taken to surgery, with successful removal of wire.

• Brand Name: MULTI-LUMEN CVC KIT
• Type of Device: MULTI-LUMEN CVC KIT
• Manufacturer (Section D): ARROW
• MDR Report Key: 9109853
• MDR Text Key: 160181273
• Report Number: 9109853
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: REF ASK-45703-PGM1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2019
• Distributor Facility Aware Date: 09/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 62