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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 24GA X 0.75IN INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 24GA X 0.75IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38833614
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Phlebitis (2004); Discharge (2225)
Event Date 02/23/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported after removing the angiocath 24ga x 0. 75in from the patient, a small amount of "yellowish secretion" was noticed coming from the insertion site due to phlebitis. No medical intervention was reported; no additional information was received as the complaint was received from the regulatory agency. As reported by the customer, "removed the peripheral venous access. Insertion present yellowish secretion in small quantity free and the expression, phlogiston signals intra and peri insertion. ".
 
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Brand NameANGIOCATH 24GA X 0.75IN
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8429320
MDR Text Key139103059
Report Number9610048-2019-00130
Device Sequence Number0
Product Code FOZ
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? Yes
Device Operator Other
Device Catalogue Number38833614
Device Lot Number8086868
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 Received03/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2018
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: 03/18/2019 Patient Sequence Number: 0
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