MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW KIT CENTRAL LINE PED 2 - LUMEN; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Catalog Number AK-12402

Device Problem Dull, Blunt (2407)

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

Event Date 02/08/2018

Event Type  Injury  

Event Description

Tip on catheter was noted to be blunted, line not attached.

• Brand Name: ARROW KIT CENTRAL LINE PED 2 - LUMEN
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; reading PA 19605
• MDR Report Key: 8336629
• MDR Text Key: 136531614
• Report Number: MW5083991
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: AK-12402
• Device Lot Number: 13F18G0217
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2019
• 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