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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38831114
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2022
Event Type  malfunction  
Event Description
It was reported that the bd insyte¿ iv catheter experienced a damaged catheter tip.The following information was provided by the initial reporter: the catheter was found with a defective tip, with a protuberance in catheter.
 
Manufacturer Narrative
Date of birth: only the patient's age was provided, therefore a default date of birth has been listed.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h10.
 
Event Description
It was reported that the bd insyte¿ iv catheter experienced a damaged catheter tip.The following information was provided by the initial reporter: the catheter was found with a defective tip, with a protuberance in catheter.
 
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Brand Name
BD INSYTE¿ 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 Key14702747
MDR Text Key295237682
Report Number9610048-2022-00056
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number38831114
Device Lot Number0300681
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age11 MO
Patient SexMale
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