MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARTERIAL CATH SET: 20 GA X 8CM; CATHETER PERCUTANEOUS

Model Number IPN920735

Device Problems Break (1069); Material Separation (1562)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: the catheter broke and separated from the fixation wings.The issue was identified prior to use.There was no patient involvement.

Event Description

It was reported that: the catheter broke and separated from the fixation wings.The issue was identified prior to use.There was no patient involvement.

Manufacturer Narrative

Qn# (b)(4).The customer returned one, unopened arterial catheterization set.No signs of use were observed on the kit or any of the components inside the kit.The kit was opened to further examine the components.Visual analysis revealed that the catheter fully intact with no evidence of a separation, and microscopic analysis of the catheter extrusion body revealed no obvious defects or anomalies.The length of the catheter measured 85mm which is within the specification limits of 82-86mm per the catheter product drawing.The catheter body outer diameter measured 1.060mm, which is within the specification limits of 1.04-1.09 mm per the catheter extrusion graphic.The catheter was functionally tested per the instructions for use (ifu) provided with this kit , which states, "thread tip of catheter over guidewire.Grasping near skin, advance catheter into vessel." the catheter was advanced over the returned guide wire with little to no resistance.A complaint history review for this failure mode over the past 5 years (01-dec-18 thru 01-dec-23) was performed for all finished good part numbers containing catheter pcz-00820-002.All complaints identified as presenting this failure mode were reported from this same customer (hospital clinic de barcelona).No other similar complaints have been reported from any other customer.A review of sales for the same finished good part numbers over the same timeframe identified a total of 2,015,761 ea sold globally in 40 different countries (94% of sales outside of spain).This indicates that the reported issue is isolated to this specific customer.A device history record review was performed, and no relevant findings were identified.The customer report of an arterial catheter separation was not confirmed through complaint investigation.The customer returned an unopened sac-00820-pbx set with no evidence of damage to the catheter.Visual, dimensional, and functional analysis revealed no obvious defects or anomalies.A device history record review was performed with no relevant findings to suggest a manufacturing issue.Based on the customer report and the sample received, no problem was found.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARTERIAL CATH SET: 20 GA X 8CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18147649
• MDR Text Key: 328261436
• Report Number: 3006425876-2023-01099
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN920735
• Device Catalogue Number: SAC-00820-PBX
• Device Lot Number: 71F23B0114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• 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