MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20 GA 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 Insufficient Information (4580)

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "catheters become blocked, despite repeated flushing.The blood pressure measurement get flat and can't no longer be measured.The samplings become impossible.The is a recurring incident." it was reported there are "ineffective blood pressure measurements for patients sometimes under high doses of amines, in a state of shock, or undergoing surgery.Impossibility to perform patients' checks at the necessary frequency." it was reported the catheter is in use "sometimes only a few hours" before the event occurs and "sometimes it is necessary to replace catheters up to 4 devices for a patient in less than 24 hours with risk of complications".There was no report of a patient injury and patient condition is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and 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: "catheters become blocked, despite repeated flushing.The blood pressure measurement get flat and can't no longer be measured.The samplings become impossible.The is a recurring incident." it was reported there are "ineffective blood pressure measurements for patients sometimes under high doses of amines, in a state of shock, or undergoing surgery.Impossiblility to perform patients' checks at the necessary frequency." it was reported the catheter is in use "sometimes only a few hours" before the event occurs and "sometimes it is necessary to replace catheters up to 4 devices for a patient in less than 24 hours with risk of complications".There was no report of a patient injury and patient condition is reported as "fine".

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15831604
• MDR Text Key: 306788225
• Report Number: 3006425876-2022-00978
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/27/2022

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: 71F22E1451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/20/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.