MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARTERIAL CATH SET: 20 GA X 5CM; CATHETER PERCUTANEOUS

Catalog Number SAC-00520-PBX

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The customer provided one photo for analysis.The photo shows a kinked guide wire within the protective tubing of an unopened arterial cath set.The customer also returned one, unopened arterial cath set for analysis.No definite signs of use were observed.Visual analysis revealed a kink on the guide wire body within the protective tubing aligning with a crease on the outside packaging.The kit was opened to better analyze the components.Microscopic analysis confirmed the kink on the guide wire aligned with the kink in the protective tubing.The lid stock clearly states, "do not bend." the damage observed is consistent with defects related to storage and shipping.No other defects or anomalies were observed.The distal and proximal welds were intact.The kink on the guide wire measured 120 mm from the distal tip.The guide wire total length measured 350 mm, which is within the specification limits of 345-355 mm per the guide wire graphic.The guide wire outer diameter measured 0.523 mm, which is within the specification limits of 0.508-0.533 mm per the guide wire graphic.Functional inspection of the guide wire was performed per the product instructions for use (ifu), which states, "insert desired tip of spring-wire guide through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle).Thread tip of indwelling catheter over spring-wire guide." the undamaged portions of the guide wire was passed through the returned 20ga introducer needle and was able to pass with little to no difficulty.A manual tug test confirmed the distal and proximal welds were attached.A device history record review was performed, and no relevant findings were identified.The lidstock was reviewed as part of this complaint investigation.The words "do not bend" are clearly visible on the front of the lidstock.The ifu provided with this kit warns the user, "do not use if package is damaged".The customer report of a kinked guide wire prior to use was confirmed through complaint investigation of the returned sample.One kink was observed on the guide wire body.The kink aligned with the crease on the protective tubing and outer packaging.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.The packaging clearly states "do not bend." based on the customer description and the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: "prior to use of the arterial catheter, the nurse observed that the swg was kinked.There was no patient involvement.".

• Brand Name: ARTERIAL CATH SET: 20 GA X 5CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19017561
• MDR Text Key: 339211360
• Report Number: 3006425876-2024-00304
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAC-00520-PBX
• Device Lot Number: 71F23M0421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2023
• 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
• Treatment: N/A.