MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. RA CATH SET: 20 GA X 1-3/4"; ARTERIAL CATHETER PRODUCTS

Catalog Number RA-04020

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported during insertion the needle became detached.The physician did not thread the wire before use as she normally does, so she was not aware of any issue until attempting to use on the patient.When the needle was inserted into the patient's artery and the physician saw the flash of blood in the chamber she then tried to thread the wire but wasn't able to fully advance it.It was noted that "this isn't unusual because of differences in patient anatomy or because of a slight bend in the catheter as it flashes." in order to salvage the catheter itself, the physician threaded the catheter down to the skin, planning to do a through and through on the artery and then pull back.At this point, the needle portion of the catheter fell off of the flash chamber.She was able to extract the needle and wire by hand leaving only the catheter still in the patient.The pressure tubing was connected as normal.The cannula became detached at the hub where the needle meets the flash chamber.There was no significant delay in treatment and no harm was caused to the patient.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the needle cannula detached from the hub during insertion of the radial artery device was confirmed.One used 20 ga radial artery device was returned without the catheter.Visual examination revealed the needle was observed to be separated from the hub.Dried blood was observed inside the guide wire tube and the guide wire / handle was stuck in the retracted position.No damage was observed during microscopic examination of the needle cannula, needle hub, and guide wire.Additionally, no adhesive residue was observed on the needle cannula or needle hub.The outside diameter of the needle cannula measured.0285 inches which meets the.0280/.0285" requirement of the needle drawing.Using pin gages, the inside diameter of the needle hub measured.030 inches which meets the.0290/.0310" requirement of the drawing.A device history record review was performed and did not reveal any manufacturing related issues.Since it appears that cannula was not sufficiently bonded into the hub, the probable cause of this issue is manufacturing related.

• Brand Name: RA CATH SET: 20 GA X 1-3/4"
• Type of Device: ARTERIAL CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5510558
• MDR Text Key: 40678711
• Report Number: 9680794-2016-00048
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: RA-04020
• Device Lot Number: 14F15E0280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1