MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 4 FR X 40 CM; CATHETER, PERCUTANEOUS

Catalog Number EU-24041-IR

Device Problem Obstruction of Flow (2423)

Patient Problem Pain (1994)

Event Date 01/08/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported the user needed to inject contrast at a very high flow rate and it was impossible to inject at a very high flow rate through the picc line.The user had to go from 4 cc/s to 1cc/s.It was reported the patient experienced pain from 3 attempts to insert a peripheral venous line and due to the time spent on an uncomfortable scanner table in supine position.The exam lasted more than 45 minutes instead of 10 minutes.The patient's condition was reported to be fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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

It was reported the user needed to inject contrast at a very high flow rate and it was impossible to inject at a very high flow rate through the picc line.The user had to go from 4 cc/s to 1cc/s.It was reported the patient experienced pain from 3 attempts to insert a peripheral venous line and due to the time spent on an uncomfortable scanner table in supine position.The exam lasted more than 45 minutes instead of 10 minutes.The patient's condition was reported to be fine.

• Brand Name: ARROW PICC KIT: 4 FR X 40 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 14409839
• MDR Text Key: 291742633
• Report Number: 3006425876-2022-00469
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/22/2022

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 Catalogue Number: EU-24041-IR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/16/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: IOMERON 400 CONTRAST; IOMERON 400 CONTRAST
• Patient Age: 72 YR
• Patient Sex: Male