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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 INTRAVASCULAR CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38182314
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). 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.
 
Event Description
It was reported that the safety mechanism of a bd insyte¿ autoguard¿ shielded iv catheter was not working properly. There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: samples/ photos: samples have not received for analysis of the incident in question. Dhr review: the following assembly batch used in the final claimed product list 7244583 was analyzed: the final assembly lot: 7241767 assembled in the period from 09/01/2017 to 09/13/2017. The batch was analyzed for "needle retraction" and ¿part activation¿ tests, and it was not evidenced record of failure of activation of the part during the analysis of these batches. Qn/ ncmr review: no records of quality notification or reports of non-conformity that could lead to incidents in to the lot involved in this complaint were evidenced. The corrective maintenance history in the manufacturing period of the assembly lot involved in this complaint was evaluated and no records were recorded that could clearly indicate a failure of the activation of the part. Investigation conclusion: not confirmed: bd was unable to confirm the claimed defect. Since samples containing the defect claimed are not available for review, this complaint was not confirmed. In addition, there are no non-conformities or corrective maintenance in the lots involved in this complaint, which could confirm the defect claimed without presence of samples.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
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 Key7534558
MDR Text Key108997624
Report Number9610048-2018-00060
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818235
UDI-Public00382903818235
Combination Product (y/n)N
Reporter Country CodeBR
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
Type of Report Initial,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2020
Device Catalogue Number38182314
Device Lot Number7244592
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 Received05/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2017
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: 05/22/2018 Patient Sequence Number: 1
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