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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ CATHETER I.V. 24GA X 0.75¿; INTRAVASCULAR CATHETER
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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ CATHETER I.V. 24GA X 0.75¿; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38831114
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported bd insyte¿ catheter i.V.24ga x 0.75¿ had a deformed catheter tip.The following information was provided by the initial reporter: ".An abnormality is identified in part of the polyurethane that covers the needle of the venocath number 24 (it is broken or "flowered").".
 
Event Description
It was reported bd insyte¿ catheter i.V.24ga x 0.75¿ had a deformed catheter tip.The following information was provided by the initial reporter: ".An abnormality is identified in part of the polyurethane that covers the needle of the venocath number 24 (it is broken or "flowered").".
 
Manufacturer Narrative
H6: investigation summary : a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 1099559, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that there was small damage on the side of the catheter tip.Based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for investigation a definitive root cause could not be determined.H3 other text : see h10.
 
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Brand Name
BD INSYTE¿ CATHETER I.V. 24GA X 0.75¿
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 Key13544360
MDR Text Key285728878
Report Number9610048-2022-00012
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,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number38831114
Device Lot Number1099559
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/04/2022
Initial Date FDA Received02/16/2022
Supplement Dates Manufacturer Received04/22/2022
Supplement Dates FDA Received05/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2021
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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