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

Catalog Number SAC-00820

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported that: "the anesthesiologist on duty proceeded to place an arterial line in the patient and when he was about to use the arterial line catheter device , it became evident that the guide was not straight, so the medical device was opened but not used.".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn # (b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a guide wire kinked was able to be confirmed by the photo.The photo shows a kinked guide wire within the protective tubing, however, a complete visual inspection could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The instructions-for-use (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.An engineering change order was implemented in april 2017 to update the product labeling to clearly inform the customer to not bend the product and is intended to reduce the potential for product damage.The customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photo.The photo shows a kinked guide wire within the protective tubing, however, full complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: "the anesthesiologist on duty proceeded to place an arterial line in the patient and when he was about to use the arterial line catheter device , it became evident that the guide was not straight, so the medical device was opened but not used.".

• 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: 19057560
• MDR Text Key: 339558938
• Report Number: 3006425876-2024-00325
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902144079
• UDI-Public: 10801902144079
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 03/12/2024

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-00820
• Device Lot Number: 71F22L0723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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