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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Phlebitis (2004)
Event Date 05/02/2016
Event Type  Injury  
Manufacturer Narrative
The date received by manufacturer has been used for this field. (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 during the time that a bd insyte autoguard shielded iv catheter was used. The patient was treated with unknown medications and his/her hospitalization was extended for an unknown length of time because of the incident.
 
Manufacturer Narrative
Results: two representative samples in sealed packages were returned for evaluation. A visual/microscopic inspection revealed that there was no foreign matter on any 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 # 5331050. The sterilization process was also reviewed and no abnormalities were found. Conclusion: an absolute root cause for this incident cannot be determined as no failure was detected.
 
Manufacturer Narrative
Correction: on the supplemental mdr submitted on 6/15/2016, the sentence, "a visual/microscopic inspection revealed that there was no foreign matter on any the units," is changed to: a visual/microscopic inspection revealed that there was no foreign matter on any of the units.
 
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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 Key5673952
MDR Text Key45753532
Report Number9610048-2016-00003
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,Followup
Report Date 06/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Catalogue Number38182314
Device Lot Number5331050
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
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: 05/23/2016 Patient Sequence Number: 1
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