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

Catalog Number SAC-00520-PBX

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Obstruction of Flow (2423)

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "artline wave form dampening frequently - requires frequent flushing.Also unable to draw bloodwork off the line.Needing to use an alternate method.As a result, the blood is clotting in the tube requiring frequent redrawing of bloodwork which increases risk of infection." no patient harm or consequence was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one image for analysis.The image showed the product issue report for this complaint.The image did not show the defective product involved with this complaint.Visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "once the catheter is partially threaded off the needle, do not attempt to advance needle into catheter again - this may cause catheter damage".The customer report of an arterial catheter kinked was not able to be confirmed by visual inspection of the customer supplied photo.Additionally, a full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.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

The complaint is reported as: "artline wave form dampening frequently - requires frequent flushing.Also unable to draw bloodwork off the line.Needing to use an alternate method.As a result, the blood is clotting in the tube requiring frequent redrawing of bloodwork which increases risk of infection." no patient harm or consequence was reported.The patient's condition is reported as fine.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15226877
• MDR Text Key: 305351583
• Report Number: 3006425876-2022-00709
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

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 Catalogue Number: SAC-00520-PBX
• Device Lot Number: 71F21L1808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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: NOT REPORTED; NOT REPORTED