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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ AUTOGUARD¿ SHIELDED IV CATHETER CATHETER SOLUTIONS

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ AUTOGUARD¿ SHIELDED IV CATHETER CATHETER SOLUTIONS Back to Search Results
Catalog Number 388332
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/16/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that during use of the bd angiocath¿ autoguard¿ shielded iv catheter the catheter separated inside the patient. A surgical procedure was performed to remove the broken catheter. The following information was provided by the initial reporter, translated from spanish to english: the catheter separated inside the patient and it was necessary to perform a procedure to remove it.
 
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Brand NameBD ANGIOCATH¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceCATHETER SOLUTIONS
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 Key9262716
MDR Text Key179110795
Report Number9610048-2019-00320
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeAR
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 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number388332
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
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: 10/31/2019 Patient Sequence Number: 1
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