MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ INTIMA-II CATHETER

Catalog Number UNKNOWN

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Phlebitis (2004)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: (b)(4). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.

Event Description

It was reported that unspecified bd¿ intima-ii catheter was used and the patient had an allergic reaction. The following information was provided by the initial reporter: after the patient was admitted to the hospital on (b)(6) 2021 due to gastroenteritis, the vein access was opened, and after two hours of intravenous drip, the family found that the puncture site of the patient's arm was red and swollen, and the patient complained of pain at the puncture site. Then i called the nurse, who found that the phlebitis was caused above the puncture site of the patient, stopped the fluid immediately, pulled out the indwelling needle and informed the doctor. Apply magnesium sulfate solution for wet compress for 15-20 minutes each time, 3-4 times a day, apply erythrycin ointment after wet compress, and recover at 9:00 am on (b)(6) 2021.

• Brand Name: UNSPECIFIED BD¿ INTIMA-II CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12339967
• MDR Text Key: 267230948
• Report Number: 2243072-2021-02104
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/26/2021
• 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 Treatment Data

Date Received: 08/18/2021 Patient Sequence Number: 1