MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX8CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN037862

Device Problem Defective Component (2292)

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

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: the user attempted to access the patient's vein with the device and when the user couldn't access the vein, she removed the entire needle/catheter from the patient.After removing the device, the user removed the catheter and the safety did not engage on the needle.No patient or user injury or complication reported.The patient's condition is reported as fine.

Event Description

The complaint is reported as: the user attempted to access the patient's vein with the device and when the user couldn't access the vein, she removed the entire n eedle/catheter from the patient.After removing the device, the user removed the catheter and the safety did not engage on the needle.No patient or user injury or complication reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one endurance assembly and lidstock for evaluation.The catheter was not returned.Visual examination revealed the needle protector was on the needle body and not at the distal end covering the sharp needle bevel.The needle protector was manually slid to the distal end of the needle and was able to engage and lock over needle tip.A device history record review did not reveal any relevant findings.The instructions for use (ifu) provided with this kit warn the user, "do not attempt to advance needle back into catheter after catheter is partially threaded off needle to reduce risk of catheter damage.Do not attempt to remove needle protection assembly from needle." the customer report of the needle protector not engaging was confirmed by complaint investigation of the returned sample.The needle protector was returned on the middle of the needle body.However, the protector was able to be manually slid to the distal end of the needle bevel and did engage properly.Based on the condition of the sample received, user error likely caused or contributed to this event.It is likely that when the clinician was removing the catheter/needle assembly from the patient they disconnected the needle protector from the catheter juncture hub.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW EXT DWELL CATH DEVICE 20GAX8CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11293638
• MDR Text Key: 230730028
• Report Number: 9680794-2021-00043
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902132960
• UDI-Public: 10801902132960
• Combination Product (y/n): N
• PMA/PMN Number: K151513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: IPN037862
• Device Catalogue Number: EDC-00820
• Device Lot Number: 14F20J0081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1