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

Catalog Number SAC-00520

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer provided two photos for analysis.The photos show two arterial catheter sets with two folds towards the distal end of the packaging.The customer also returned one, unopened arterial catheter set for analysis.The returned packaging had two major folds towards the distal end.Visual analysis revealed one of the fold towards the distal end of the pouch aligns with a kink in the protective tubing and the guide wire within.The lid stock clearly states , "do not bend." the damage observed is consistent with defects related to storage and shipping.The package was opened to analyze the contents within.One kink was confirmed on the guide wire.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kink on the guide wire measured 29 mm from the distal tip.The guide wire length measured 350 mm, which is within the specification limits of 345-355 mm per the guide wire product drawing.The guide wire outer diameter measured 0.511 mm, which is within the specification limits of 0.508-0.533 mm per the guide wire product drawing.The guide wire was advanced through the returned 20ga introducer needle and catheter.The undamaged portions of the guide wire passed with little to no resistance.Performed per instructions for use (ifu) statement, "insert tip of guidewire through introducer needle into artery (until depth marking [if provided] on wire enters hub of needle).Thread tip of catheter over guidewire.Precaution: allow sufficient guidewire length to remain exposed at hub end of catheter to maintain firm grip on guidewire.Grasping near skin, advance catheter into vessel." a manual tug test confirmed that the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user , "do not use if package is damaged".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 customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.One kink was observed on the guide wire body and protective tubing.The returned packaging had two major creases towards the distal end and one towards the proximal end.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: during the receipt and labeling inspection we found the product and packaging damaged (dented) inside the box." the returned samples were found to have kinked guidewires.

• 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: 19057531
• MDR Text Key: 339559555
• Report Number: 3006425876-2024-00329
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902144062
• UDI-Public: 10801902144062
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/14/2024

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
• Device Lot Number: 71F22B1289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2022
• 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