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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

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BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM Back to Search Results
Catalog Number 383033
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abrasion (1689); Infiltration into Tissue (1931); Local Reaction (2035)
Event Date 07/08/2019
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 was reported that bd intima-ii¿ closed iv catheter system was used and the patient had a skin reaction. This was discovered during use. The following information was provided by the initial reporter: on july 1, the patient was admitted to hospital according to the emergency plan of "left calf soft tissue file abrasion". After admission, the patient was treated with intravenous infusion with indwelling needle in the left forearm (apricotine). On july 3, the indwelling needle eye was slightly red, and the indwelling needle was removed. On the morning of july 4, the patient's left forearm indwelling needle eye was red, with local indwelling, damage, and a small amount of infiltration, with a range of about 1. 5cm*1. 5cm. On july 5, the indwelling needle infusion was given to the right wrist, and the indwelling needle was removed at 17:00 p. M. On the morning of july 6, 1cm*1cm skin redness and a small amount of exudation were observed at the puncture site of the indwelling needle in the right wrist. After consultation, the ulcer was applied for external use.
 
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Brand NameBD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
Type of DeviceCATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9526389
MDR Text Key182211902
Report Number3006948883-2019-01131
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
Number of Events Reported1
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 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/04/2021
Device Catalogue Number383033
Device Lot Number8233335
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 Received12/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2018
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: 12/27/2019 Patient Sequence Number: 1
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