MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 5-LUMEN 8.5FR X 16CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number SA-22855-EU

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: on insertion of the cvc, the raulerson syringe leaks air on aspiration.A new kit was opened.No patient harm reported.

Event Description

The complaint is reported as: on insertion of the cvc, the raulerson syringe leaks air on aspiration.A new kit was opened.No patient harm 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.

• Brand Name: ARROW CVC KIT: 5-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13216246
• MDR Text Key: 283630288
• Report Number: 3006425876-2022-00085
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 12/17/2021

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 Expiration Date: 03/31/2023
• Device Catalogue Number: SA-22855-EU
• Device Lot Number: 71F21D1594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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