MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN919773

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

Qn(b)(4).

Event Description

It was reported that "difficult to insert the cvc's guidewire through the dilator via left supraclavicular under guided ultrasound and easy puncture.The 1st dilation was done around 3cm, but couldn't advance the dilator further despite an incision with bistoury to facilitate the insertion of the dilator (no difficulties felt in the first few cm).Impossible to insert the cvc.New dilation still difficult but with better progression until the cvc was inserted.When removing the dilator, we observed that the tip was fragmented but all fragments were accounted for." no patient harm was reported.

Manufacturer Narrative

(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

It was reported that "difficult to insert the cvc's guidewire through the dilator via left supraclavicular under guided ultrasound and easy puncture.The 1st dilation was done around 3cm, but couldn't advance the dilator further despite an incision with bistoury to facilitate the insertion of the dilator (no difficulties felt in the first few cm).Impossible to insert the cvc.New dilation still difficult but with better progression until the cvc was inserted.When removing the dilator, we observed that the tip was fragmented but all fragments were accounted for." no patient harm was reported.

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 15142387
• MDR Text Key: 302519136
• Report Number: 3006425876-2022-00661
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/30/2023
• Device Model Number: IPN919773
• Device Catalogue Number: CS-42802
• Device Lot Number: 71F21M1176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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