MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN CVC KIT; CATHETER, PERCUTANEOUS

Lot Number 13F19E0655

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2020

Event Type  malfunction  

Event Description

Pt had a triple lumen arrow central line in place with the second site adjustable hub and catheter clamp utilized to hold the line in place.When wet / damp / cleaned the central line easily moves out of the second site adjustable hub and catheter clamp.On this pt, the central line inadvertently fell out when it got wet.This is the second pt this has occurred in and an add'l medwatch will be filed for that pt.Therapy dates: (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: MULTI-LUMEN CVC KIT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC. ; reading PA 19605
• MDR Report Key: 9883244
• MDR Text Key: 185223647
• Report Number: MW5093936
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Lot Number: 13F19E0655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2020
• 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: 66 YR
• Patient Weight: 79