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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 24GA X 0.75IN CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 24GA X 0.75IN CATHETER Back to Search Results
Catalog Number 38831114
Device Problem Break (1069)
Patient Problem Hematoma (1884)
Event Date 03/30/2021
Event Type  malfunction  
Manufacturer Narrative
Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. 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 insyte 24ga x 0. 75in catheter tip damaged. The following information was provided by the initial reporter: at the moment of the procedure, the bevel is dull compromising the catheter insertion, when introducing the catheter it splits and leads to a damage to newborn's skin. On 04/07/2021: add info received. Requested for a better description of how and where the catheter broke; the catheter does not break but the cap does not enter, it opens at the tip and the needle is blunt for incision in the patient. Requested for the confirmation if there was no medical intervention required due to skin harm; there was no need for intervention.
 
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Brand NameINSYTE 24GA X 0.75IN
Type of DeviceCATHETER
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11742614
MDR Text Key247901274
Report Number9610048-2021-00066
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number38831114
Device Lot Number9115991
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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