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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD 10CC SYRINGE

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BD BD 10CC SYRINGE Back to Search Results
Device Problems Burst Container or Vessel (1074); Split (2537)
Patient Problems Eye Injury (1845); Injury (2348)
Event Date 07/03/2017
Event Type  malfunction  
Event Description
On 07/03/2017 - during a neuro procedure a 10cc bd syringe split while injecting contrast. The syringe sprayed neuro doctor in eye with blood and contrast, and also sprayed the staff with blood and contrast - given to dave ortolani from cardinal health.
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Type of DeviceBD 10CC SYRINGE
Manufacturer (Section D)
MDR Report Key6718074
MDR Text Key80185052
Report NumberMW5071021
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/17/2017 Patient Sequence Number: 1