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 Discomfort (2330)

Event Date 01/18/2023

Event Type  malfunction  

Event Description

Customer complaint reported as: "the patient came back from the surgery room on (b)(6) 2023.It was impossibility to take blood sample, there was no curve of the arterial pressure.The patient returned from the surgery room on (b)(6) evening with a dysfunctional catheter but with which it was possible to take the sample the next morning.However, the pressure monitoring did not work.We monitored the arterial pressure manually.On (b)(6) the catheter was still inserted as we thought that we could take sample.On 25 january morning at 6 am despite a new dressing and some manipulations to try to make it work, it was impossible take sample." the patient consequence is reported as: "at first it was disturbing for the patient's sleep and for her comfort (we added a monitoring non-invasive).There was a risk of infection.Finally, it was necessary to puncture the patient in arterial despite a normal suitable equipment.This patient was particularly confused and agitated with this care.We did not manage to have this catheter being functional afterwards.The device was discarded.".

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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

Customer complaint reported as: "the patient came back from the surgery room on (b)(6) 2023.It was impossibility to take blood sample, there was no curve of the arterial pressure.The patient returned from the surgery room on (b)(6) evening with a dysfunctional catheter but with which it was possible to take the sample the next morning.However, the pressure monitoring did not work.We monitored the arterial pressure manually.On (b)(6) the catheter was still inserted as we thought that we could take sample.On (b)(6) morning at 6 am despite a new dressing and some manipulations to try to make it work, it was impossible take sample." the patient consequence is reported as: "at first it was disturbing for the patient's sleep and for her comfort (we added a monitoring non-invasive).There was a risk of infection.Finally, it was necessary to puncture the patient in arterial despite a normal suitable equipment.This patient was particularly confused and agitated with this care.We did not manage to have this catheter being functional afterwards.The device was discarded.".

• 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: 16433275
• MDR Text Key: 310365901
• Report Number: 3006425876-2023-00168
• 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: 01/27/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 03/17/2023
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.
• Patient Age: 87 YR
• Patient Sex: Female