MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number CS-14402

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Extravasation (1842); Skin Inflammation (2443)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: it was reported that the catheter was placed in the patient around (b)(6) 2020.On (b)(6) 2020, after vancomycin injection, the user found that the clothes around the patient's right side of neck and the pillow were wet.Then, when the user flushed saline, a leak from the injection site was confirmed.The skin around the injection site became a little puffy and stiff.As the user suspected that the catheter might have broken, he/she removed the catheter ,and replaced with a new one.No serious injury to the patient occurred, and the "cultivation test result" showed that the catheter was negative for infection.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo for evaluation.Visual inspection of the photo revealed a hole in the catheter body.This hole is consistent with the appearance of the proximal skive hole, which is intentionally manufactured on the catheter extrusion to distribute any fluids when injecting through the proximal lumen.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, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the complaint of hole in the catheter body could not be confirmed by the customer photo.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 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: it was reported that the catheter was placed in the patient around (b)(6) 2020.On (b)(6)2020, after vancomycin injection, the user found that the clothes around the patient's right side of neck and the pillow were wet.Then, when the user flushed saline, a leak from the injection site was confirmed.The skin around the injection site became a little puffy and stiff.As the user suspected that the catheter might have broken, he/she removed the catheter and replaced with a new one.No serious injury to the patient occurred, and the "cultivation test result" showed that the catheter was negative for infection.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10825788
• MDR Text Key: 216231185
• Report Number: 3006425876-2020-00944
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CS-14402
• Device Lot Number: 71F19H1109
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.