MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 22 GA X 4" (10 CM); CATHETER PERCUTANEOUS

Catalog Number ES-04522-BZ

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports no progression of the guidewire in the subclavian vein, during catheter implantation.It did not progress and dented during the attempt.Patient is a newborn.Another device was inserted.

Event Description

The customer reports no progression of the guidewire in the subclavian vein, during catheter implantation.It did not progress and dented during the attempt.Patient is a newborn.Another device was inserted.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 22 GA X 4" (10 CM)
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10367096
• MDR Text Key: 201696806
• Report Number: 9680794-2020-00325
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K810962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ES-04522-BZ
• Device Lot Number: 14F19F0313
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1