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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD CATETER I.V. 18G X 1.16 (1.3 X 30 MM) (LATIN AMERICA) INTERVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE AUTOGUARD CATETER I.V. 18G X 1.16 (1.3 X 30 MM) (LATIN AMERICA) INTERVASCULAR CATHETER Back to Search Results
Model Number 381844
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the bd insyte¿ autoguard¿ catheter i. V. 18g x 1. 16¿ (1. 3 x 30 mm) (latin america) experienced the needle piercing the needle shield/cap/cover prior to use. The following information was provided by the initial reporter: the material is thought the protective shield. There is no patient involved in the event.
 
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Brand NameBD INSYTE AUTOGUARD CATETER I.V. 18G X 1.16 (1.3 X 30 MM) (LATIN AMERICA)
Type of DeviceINTERVASCULAR 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 Key10655701
MDR Text Key211849085
Report Number9610048-2020-00141
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381844
Device Catalogue Number38184414
Device Lot Number0077471
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 Received11/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2020
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: 10/09/2020 Patient Sequence Number: 1
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