MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 22 GA X 5CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-00522

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that: "the hcp found catheter kinked prior to use on patient.".

Manufacturer Narrative

(b)(4).The customer returned one, opened arterial cath set for analysis.Visual analysis revealed major folds and creases throughout the packaging.The guide wire within the protective tubing had three kinks with kinks observed on the protective tubing.The introducer needle was within its guard, and both were bent.The lidstock clearly states, "do not bend." the damage observed is consistent with defects related to storage and shipping.It is likely both the damaged components were kinked as a result of the folds in the packaging.The guide wire was removed from within the catheter and a total of three kinks were confirmed on the guide wire.Microscopic examination confirmed the damage and revealed that the distal and proximal welds of the guide wire were secure and intact.The kinks on the guide wire measured 148mm, 152mm, and 181mm from the proximal tip.The guide wire length measured 350 mm which is within the specification limits per the guide wire product drawing.The guide wire outer diameter (od) measured 0.513 mm, which is within the specification limits per the guide wire product drawing.The guide wire was advanced through the returned catheter, and the undamaged portions were able to pass with little to no resistance.Performed per instructions-for-use (ifu) statement "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 device history record review was performed, and no relevant findings were identified.The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Three kinks were ob served on the guide wire body.The returned packaging had multiple creases likely resulting in the damage observed on the protective tubing and the guide wire within.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.

• Brand Name: ARROW ARTERIAL CATH SET: 22 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: 19002485
• MDR Text Key: 338889813
• Report Number: 3006425876-2024-00316
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902102751
• UDI-Public: 00801902102751
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/05/2024

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-00522
• Device Lot Number: 71F23D2741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/02/2023
• 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