MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CG+ PICC/DELTA KIT: 1-L 4.5 FR X 50 CM; INTRODUCER, CATHETER

Catalog Number CDC-45041-VPS2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Itching Sensation (1943); Reaction (2414)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports a picc catheter was placed.It's reported a patient experienced a severely moderate allergic reaction to the arrow 4.5 coated picc catheter.When the picc line was dressed, the patient started itching and scratching his entire upper body.His entire skin, as visualize, became very red and patient stated that he was dizzy and was having difficulty catching his breath.The catheter was immediately removed.Oxygen, benadryl iv and solumedrol were given.The patient then significantly improved.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 a picc catheter was placed.It's reported a patient experienced a severely moderate allergic reaction to the arrow 4.5 coated picc catheter.When the picc line was dressed, the patient started itching and scratching his entire upper body.His entire skin, as visualize, became very red and patient stated that he was dizzy and was having difficulty catching his breath.The catheter was immediately removed.Oxygen, benadryl iv and solumedrol were given.The patient then significantly improved.

• Brand Name: ARROW CG+ PICC/DELTA KIT: 1-L 4.5 FR X 50 CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7673553
• MDR Text Key: 113529049
• Report Number: 1036844-2018-00189
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: CDC-45041-VPS2
• Device Lot Number: 23F18C0071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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
• Patient Outcome(s): Required Intervention