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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
Model Number 381823
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #: (b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had a defect in the filter, causing fluid leakage.The following information was provided by the initial reporter, translated from portuguese: "one unit of the batch had a defect in the filter, causing fluid leakage.¿.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09aug2022.Bd received a used catheter from an unknown lot for evaluation.The catheter was received in an open package and not the original product packaging.A review of the device history record was performed for the reported lot, 1111254, and no quality issues were found during production.Our quality engineer visually inspected the returned catheter and identified that the catheter was not a bd product.Also, two photos of the defect were provided but not enough evidence was visible in the provided photos to determine any possible defects.Therefore, based off the visual inspection the engineer could not verify this as a manufacturing defect.Since, the defect was determined to not be a bd product a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.Were received at bd juiz de fora on 09-aug2022, 01 sample used, containing only the catheter, in open packaging and not original product.The sample was received by the person responsible for the analysis and sent for decontamination.According to the visual analysis of the samples, it can be seen that the catheter sent by the customer is not a bd product.H3 other text : see h.10.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had a defect in the filter, causing fluid leakage.The following information was provided by the initial reporter, translated from portuguese: "one unit of the batch had a defect in the filter, causing fluid leakage.¿.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14960343
MDR Text Key304377977
Report Number9610048-2022-00068
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818235
UDI-Public00382903818235
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 Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2024
Device Model Number381823
Device Catalogue Number38182314
Device Lot Number1111254
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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