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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; INTRAVASCULAR CATHETER
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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE 24GA X 0.75IN; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38831114
Device Problem Break (1069)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that insyte 24ga x 0.75in had a damaged tip.The following information was provided by the initial reporter: "at the moment of taking the catheter off of its package, it was observed that it was bent in the plastic part tip".
 
Manufacturer Narrative
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, 9177504, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the needle had pierced through the catheter tubing.Based off the provided photo the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred during the catheter placement process.The was a misalignment between the needle and the catheter when it was applied and it had pierced through the tubing.The manufacturing facility has been notified of this incident and the findings.
 
Event Description
It was reported that insyte 24ga x 0.75in had a damaged tip.The following information was provided by the initial reporter: "at the moment of taking the catheter off of its package, it was observed that it was bent in the plastic part tip".
 
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Brand Name
INSYTE 24GA X 0.75IN
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
MDR Report Key11072386
MDR Text Key223635062
Report Number9610048-2020-00188
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 03/28/2021
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 Other
Device Catalogue Number38831114
Device Lot Number9177504
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/24/2020
Supplement Dates Manufacturer Received03/12/2021
Supplement Dates FDA Received04/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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