MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER INTRAVASCULAR THERAP

Catalog Number CDA-45703-P1A

Device Problem Obstruction of Flow (2423)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: in the operating room, when the catheter was inserted "they detected that it was obstructed, and they could not apply the medicine". No patient harm reported. No report of required intervention. The patient's condition is reported as fine.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 11142110
• MDR Text Key: 226095055
• Report Number: 9680794-2021-00013
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2022
• Device Catalogue Number: CDA-45703-P1A
• Device Lot Number: 13F20F0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial