MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER

Catalog Number 383069

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

Patient Problems Local Reaction (2035); Skin Inflammation (2443)

Event Date 09/08/2019

Event Type  Injury  

Manufacturer Narrative

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 has been reported that one bd intima-ii¿ closed iv catheter system has been found experiencing adverse effects without apparent device misuse or problem during use. The following has been provided by the initial reporter: on (b)(6) 2019, the patient came to our hospital for viral influenza. It needed to be infused for three days. The doctor used a closed intravenous indwelling needle for infusion. The next day, there was redness at the puncture site. The doctor replaced the closed intravenous indwelling needle and with anti-inflammatory treatment. Better after 1 day.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9189359
• MDR Text Key: 164022309
• Report Number: 3006948883-2019-00864
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/19/2022
• Device Catalogue Number: 383069
• Device Lot Number: 8358924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2018
• 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: 10/14/2019 Patient Sequence Number: 1