MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-26702-E

Device Problem Leak/Splash (1354)

Patient Problems Injury (2348); No Information (3190)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the lumen is damaged and therefore leaking.It is reported that the patient was exposed to infectious disease.At the time of placement of the cvc the patient was septic and had a fever.

Manufacturer Narrative

Qn# (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.

Event Description

The customer reports: the lumen is damaged and therefore leaking.It is reported that the patient was exposed to infectious disease.At the time of placement of the cvc the patient was septic and had a fever.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10230746
• MDR Text Key: 198492098
• Report Number: 3006425876-2020-00565
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: CV-26702-E
• Device Lot Number: 71F19D2885
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR