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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20 G X 1.16 IN. INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20 G X 1.16 IN. INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38183414
Device Problem Fail-Safe Design Failure (1222)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2017
Event Type  malfunction  
Manufacturer Narrative
Bd awareness date was reported incorrectly as (b)(6) 2014 on initial mdr. The correct awareness date was (b)(6) 2017. Samples or photos have not received for analysis of the incident in question. Dhr/qn/ncmr review: assembled lot: 7151597, used in the claimed final product lot: 7151712 of insyte autoguard 20g x 1. 16 was analyzed for "needle retraction" and ¿part activation¿ tests, and were no evidenced failure in the activation of the part during analysis of these batches. Bd was unable to confirm the incident in question. As samples are not available for analysis of this complaint and as no objective evidence of this issue was evidenced during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to confirm this complaint. Based on the investigations of this complaint, it was not possible to assign a root cause for the incident.
 
Manufacturer Narrative
Initial reporter phone#: (b)(6). A sample is not available for evaluation. However, a no sample investigation and device history record review will be completed. Upon completion of the investigation, a supplemental report will be filed. Udi#: (b)(4).
 
Event Description
It was reported that the safety mechanism of the bd insyte¿ autoguard¿ shielded iv catheter 20 g x 1. 16 in. Failed to work properly, leaving the needle exposed. There was no report of injury or medical interventions.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20 G X 1.16 IN.
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
8015652845
MDR Report Key6930871
MDR Text Key250327842
Report Number9610048-2017-00037
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2020
Device Catalogue Number38183414
Device Lot Number7151712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2017
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: 10/09/2017 Patient Sequence Number: 1
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