MAUDE Adverse Event Report: ARROW INTERNATIONAL INC., / SUBSIDIARY OF TELEFLEX ARROW INTERNATIONAL TELEFLEX KIT AK-21242-CDC; CATHETER, PERCUTANEOUS

Model Number 21242

Device Problems Break (1069); Migration or Expulsion of Device (1395)

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

Event Date 04/08/2019

Event Type  malfunction  

Event Description

Cvc arrow ak-21242-cdc reported the sheath is not locking and the device is breaking leading to catheter migration.Arrow international / teleflex discontinued the previous product in july 2018.Reported as a concern in cardiac - operating room.Fda safety report id# (b)(4).

• Brand Name: ARROW INTERNATIONAL TELEFLEX KIT AK-21242-CDC
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC., / SUBSIDIARY OF TELEFLEX
• MDR Report Key: 8523127
• MDR Text Key: 142469289
• Report Number: MW5085933
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21242
• Device Catalogue Number: 21242-CDC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2019
• 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