MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number IPN919475

Device Problem Unraveled Material (1664)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Customer complaint reports: when inserting a catheter after inserting the introducer needle and the guidewire, nurses wanted to remove the introducer needle but the guidewire unravelled at the time of removal.The nurses therefore had to remove it entirely by pulling on it.It was reported the incident led to a postponement of dialysis and the patient also bled heavily.Additional information received from customer on (b)(6) 2022 reports patient was thrombocytopenic and therefore at greater risk of bleeding.Patient condition is "fine".No medical intervention was required.

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

Qn# (b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of guidewire and needle resistance - unraveled was able to be confirmed by the photo as it revealed an unraveled guidewire after use.A complete 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 instructions for use (ifu) provided with this kit warns the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire.Do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the complaint was able to be confirmed by the photo as it revealed an unraveled guidewire after use.However, 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

Customer complaint reports: when inserting a catheter after inserting the introducer needle and the guidewire, nurses wanted to remove the introducer needle but the guidewire unravelled at the time of removal.The nurses therefore had to remove it entirely by pulling on it.It was reported the incident led to a postponement of dialysis and the patient also bled heavily.Additional information received from customer on 30dec2022 reports patient was thrombocytopenic and therefore at greater risk of bleeding.Patient condition is "fine".No medical intervention was required.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 20 CM
• 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: 16226617
• MDR Text Key: 308459837
• Report Number: 3006425876-2023-00131
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

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 Model Number: IPN919475
• Device Catalogue Number: CS-15123-F
• Device Lot Number: 71F21J2224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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