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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY SET, ADMINISTRATION, INTRAVASCULAR

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BECTON, DICKINSON AND COMPANY SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Material Split, Cut or Torn (4008)
Patient Problem Discomfort (2330)
Event Date 11/10/2020
Event Type  malfunction  
Event Description
An attempt to start a peripheral iv on the patient's right antecubital vein for iv contrast. Iv catheter noted to be intact prior to insertion. Once inserted it was noted a quick, small blood flash, then started to meet some resistance, and patient complaint of discomfort. Catheter removed. It was noted a few mm of the catheter split off from the tip of the needle. No pieces of the catheter missing upon inspection. Catheter saved to be given to the product specialist nurse for review. No ill effects to the patient.
 
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Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key11071840
MDR Text Key223621861
Report Number11071840
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2020
Event Location Hospital
Date Report to Manufacturer12/24/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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