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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 38181214
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Phlebitis (2004)
Event Date 05/02/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a patient developed phlebitis and an abscess during the time that a bd insyte¿ autoguard¿ shielded iv catheter was used. The patient's hospitalization was extended for monitoring because of the incident, however no medical or surgical interventions were provided.
 
Manufacturer Narrative
Two representative samples in sealed packages were returned for evaluation. A visual/microscopic inspection revealed that there was no foreign matter on any of the units. The bevel area had the proper bevel cut and the secondary bevel was present. The lie distance was within the acceptable range of. 001 - 0. 023 inches. The cannula tip quality on both units rated b - acceptable. No bends holes, kinks splits or wrinkles were found in the catheter tubing. The catheter tip grading for both units graded a 5 (slightly rough or uneven edge to clean sharp edge) - acceptable. A package leak test was performed and revealed no leaks or opened seals. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5203334. The sterilization process was also reviewed and no abnormalities were found. A quality notification revie revealed one qn ((b)(4)) that could be associated with this incident. The qn involved jagged tip, o-rings and flashed tips. The suspect product was scrapped and is not be an issue for this particular incident. Conclusion: an absolute root cause for this incident cannot be determined as no failure was detected.
 
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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 Key5661343
MDR Text Key45370556
Report Number9610048-2016-00002
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 distributor,foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2018
Device Catalogue Number38181214
Device Lot Number5203334
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2015
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: 05/17/2016 Patient Sequence Number: 1
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