MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET; CATHETER, INTRAVASCULAR, THER

Catalog Number VASCULAR UNKNOWN

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Infiltration into Tissue (1931)

Event Date 04/25/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported patient had picc line placed at outside facility.Patient had a ct scan and after contrast injection, the site looked infiltrated and the patient was sent to the emergency room for assessment.The picc dressing was noted to be wet with insertion area leaking fluid and 1 cm of line external.The distal line was noted to have no blood return and when flushed noted saline bubbling from insertion site.When the line was removed, a fracture was noted at the 2cm mark.No patient harm or injury reported.The patient's condition was reported to be fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned one 2-l picc for analysis.Signs of use were observed on the catheter and inside the extension lines.Visual inspection of the catheter revealed a hole on the catheter body.The hole appeared stretched.This damage is consistent with unintentional over pressurization of the lumens during use.The slit in the catheter was located 22 mm from the juncture hub.Functional inspection was performed on the catheter in order to replicate its intended use.Both extension lines were flushed with water using a lab inventory 5cc syringe.When flushing the distal extension line, water leaked out of the hole in the catheter body.The proximal extension line flushed as expected, with no observed leaks or blockages.A manual tug test confirmed both extension lines were secured to their respective luer hubs.The customer report of a catheter leak in use was confirmed through complaint investigation of the returned sample.Visual inspection confirmed a hole in the catheter body near the juncture hub.Based on the customer report and the results of this investigation, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported patient had picc line placed at outside facility.Patient had a ct scan and after contrast injection, the site looked infiltrated and the patient was sent to the emergency room for assessment.The picc dressing was noted to be wet with insertion area leaking fluid and 1 cm of line external.The distal line was noted to have no blood return and when flushed noted saline bubbling from insertion site.When the line was removed, a fracture was noted at the 2cm mark.No patient harm or injury reported.The patient's condition was reported to be fine.

• Brand Name: ARROW PICC SET
• Type of Device: CATHETER, INTRAVASCULAR, THER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 14456882
• MDR Text Key: 292204780
• Report Number: 9680794-2022-00307
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: CT CONTRAST; CT CONTRAST