MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC KIT: 2-L 5 FR X 55 CM WITH PRELO; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CDC-35552-VPS

Device Problem Migration (4003)

Patient Problem Tachycardia (2095)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

Patient had picc placed in right basilic vein on (b)(6) 2022.Total length 47 cm, extension length 5cm.Tip placement verification done by arrow vascular positioning system (vps) and a blue bullseye was obtained, confirming placement.On (b)(6) 2022, the patient had some "runs" of v-tach during the night.A portable chest x-ray was done and showed the picc tip in the right atrium.The radiologist advised to pull picc back 5cm.The user noted the picc dressing was intact with a large blood clot noted at insertion site and extension at 5cm.A dressing change was performed and the picc was pulled back 5cm, now total extension length at 10cm.A repeat x-ray was done and showed the tip was at the caj.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

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

Patient had picc placed in right basilic vein on (b)(6) 2022.Total length 47 cm, extension length 5cm.Tip placement verification done by arrow vascular positioning system (vps) and a blue bullseye was obtained, confirming placement.On (b)(6) 2022, the patient had some "runs" of v-tach during the night.A portable chest x-ray was done and showed the picc tip in the right atrium.The radiologist advised to pull picc back 5cm.The user noted the picc dressing was intact with a large blood clot noted at insertion site and extension at 5cm.A dressing change was performed and the picc was pulled back 5cm, now total extension length at 10cm.A repeat x-ray was done and showed the tip was at the caj.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PI PICC KIT: 2-L 5 FR X 55 CM WITH PRELO
• 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: 13444449
• MDR Text Key: 286647573
• Report Number: 9680794-2022-00054
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: CDC-35552-VPS
• Device Lot Number: 13F21J0598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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
• Treatment: NOT REPORTED.; NOT REPORTED.