MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-25703-E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

The complaint is reported as: "the needle is not absorbed.The needle does not absorb, there is evidence of water leakage.The doctor used another catheter." no patient harm reported.

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "the needle is not absorbed.The needle does not absorb, there is evidence of water leakage.The doctor used another catheter." no patient harm reported.

Manufacturer Narrative

(b)(4).The actual sample was not returned; however, the customer provided one photo for analysis.The complaint of an arrow raulerson syringe leaking in use was not able to be confirmed by the photo.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 aspirate arrow raulerson syringe while guidewire is in place; air may enter syringe through rear valve.Precaution: do not reinfuse blood to reduce risk of blood leakage from rear (cap) of syringe." 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.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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: 13642814
• MDR Text Key: 286513894
• Report Number: 3006425876-2022-00198
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

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 Expiration Date: 04/24/2023
• Device Catalogue Number: CV-25703-E
• Device Lot Number: 71F21E0394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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
• Patient Age: 81 YR