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

Model Number IPN038310

Device Problem Material Separation (1562)

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

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "a patient went to the nephrology department on (b)(6) 2022 for taking care of hypertensive acute lung edema with dialysis complicated by ischemic and valvular heart disease.The catheter was inserted on left femoral.On (b)(6) 2022, the catheter was found with a three-quarter came off bandage, the puncture site was at the air and the extension line separated.The catheter was clamped.There was no hemorrhage and no air in the central line.There was no complication related to this incident.The patient was moved to trendelenburg position and left in bed for 1 hour, under increased surveillance.The constants remained normal (ta 12/65, pulse 72, oxygen saturation normal (95 in air)), with no clinical signs suggestive of gas embolism.After consulting the doctor, the catheter was removed.".

Manufacturer Narrative

(b)(6).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: "a patient went to the nephrology department on (b)(4) 2022 for taking care of hypertensive acute lung edema with dialysis complicated by ischemic and valvular heart disease.The catheter was inserted on left femoral.On (b)(4) 2022, the catheter was found with a three-quarter came off bandage, the puncture site was at the air and the extension line separated.The catheter was clamped.There was no hemorrhage and no air in the central line.There was no complication related to this incident.The patient was moved to trendelenburg position and left in bed for 1 hour, under increased surveillance.The constants remained normal (ta 12/65, pulse 72, oxygen saturation normal (95 in air)), with no clinical signs suggestive of gas embolism.After consulting the doctor, the catheter was removed.".

Event Description

The complaint is reported as: "a patient went to the nephrology department on (b)(6)2022 for taking care of hypertensive acute lung edema with dialysis complicated by ischemic and valvular heart disease.The catheter was inserted on left femoral.On(b)(6)2022, the catheter was found with a three-quarter came off bandage, the puncture site was at the air and the extension line separated.The catheter was clamped.There was no hemorrhage and no air in the central line.There was no complication related to this incident.The patient was moved to trendelenburg position and left in bed for 1 hour, under increased surveillance.The constants remained normal (ta 12/65, pulse 72, oxygen saturation normal (95 in air)), with no clinical signs suggestive of gas embolism.After consulting the doctor, the catheter was removed.".

Manufacturer Narrative

Qn#(b)(4).The customer returned a 3-l cvc catheter and additional extension tubing for evaluation.Signs of use in the form of biological material were found on the catheter body.Visual inspection of the catheter confirmed the distal extension line was separated approximately 9 mm from the luer hub.The separation points were found to be smooth, consistent with a sharp instrument such as a scalpel or scissors contacting the extension line.The total length of the catheter body measured 218 mm, which is within specifications of 207-227 mm per catheter graphic.The distal extension line was separated 9 mm, from the luer hub.The outer diameter of the distal extension line measured 1.728 mm, which is within specifications of 1.68-1.78 mm per distal extension line extrusion graphic.The inner diameter of the distal extension line measured 1.1684 mm which is within specifications of 1.14-1.24 mm per distal extension line extrusion graphic.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "prepare the catheter for insertion by flushing each lumen and clamping or attaching the injection caps to the appropriate extension lines." both the proximal and medial lines flushed as expected.A manual tug test confirmed the proximal and medial luer hubs were secure to their extension lines.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not suture directly to the outside diameter of the catheter to minimize the risk of cutting or damaging the catheter or impeding catheter flow.To minimize the risk of cutting the catheter do not use scissors to remove the dressing." the complaint of an extension line separated/torn during use was confirmed by investigation of the returned sample.The distal extension line had separated near the luer hub.The separation points were smooth , consistent with a sharp object cutting the extension line.A device history record review was performed, and no relevant findings were identified.Based on the customer description and the sample returned , unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 20 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: 14457996
• MDR Text Key: 292204449
• Report Number: 3006425876-2022-00463
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K970864
• 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,Followup
• Report Date: 04/27/2022

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 Operator: Health Professional
• Device Model Number: IPN038310
• Device Catalogue Number: CS-15123-F
• Device Lot Number: 71F20J1948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/16/2022; 11/30/2022
• Supplement Dates FDA Received: 06/16/2022; 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2020
• 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; NOT REPORTED