MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROWGARD BLUE PLUS PRESSURE INJECTABLE MULTI-LUMEN; CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number CDC-42703-P1A

Device Problems Break (1069); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 12/17/2018

Event Type  No Answer Provided  

Event Description

Md was attempting to place a triple lumen in a critical patient when the introducer wire made a 90 degree bend and could not be advanced.A second triple lumen kit was opened and also had a problem with this wire.The wire in the second kit stripped.Both kits were unusable.Different product was used successfully.

• Brand Name: ARROWGARD BLUE PLUS PRESSURE INJECTABLE MULTI-LUMEN
• Type of Device: CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.
• MDR Report Key: 8186089
• MDR Text Key: 131335721
• Report Number: MW5082351
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: CDC-42703-P1A
• Device Lot Number: 13F18D0506
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2018
• 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: 43 YR
• Patient Weight: 47