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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE; PERIPHERAL IV CATHETERS

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE; PERIPHERAL IV CATHETERS Back to Search Results
Catalog Number 38831114
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2024
Event Type  malfunction  
Event Description
It was reported that bd insyte catheter bend during infusion.The following information was provided by the initial reporter, translated from spanish to english: it is possible that it has advanced with a mandrel, then it is removed and the catheter is wrinkled in the technical channeling part.After 30 minutes of canalization and patent vein, the catheter is folded.The catheter had to be removed.
 
Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
 
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Brand Name
BD INSYTE
Type of Device
PERIPHERAL IV CATHETERS
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
BR 
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
BR  
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key19215742
MDR Text Key341829721
Report Number9610048-2024-00043
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903883110
UDI-Public(01)00382903883110
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/26/2024
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 Number3062305
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/04/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age9 MO
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