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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY N/A; SYRINGE, SALINE, PREFILLED
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BECTON, DICKINSON AND COMPANY N/A; SYRINGE, SALINE, PREFILLED Back to Search Results
Model Number 306507
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 03/06/2018
Event Type  malfunction  
Event Description
Rn went to use pre-filled 3ml saline syringe.Upon taking the syringe out of the sealed package, rn noticed that syringe was not completely filled and there was orange/brown sediment in the syringe.Pre-filled saline syringe was not used and all others in stock were checked and not affected.
 
Event Description
Rn went to use pre-filled 3ml saline syringe.Upon taking the syringe out of the sealed package, rn noticed that syringe was not completely filled and there was orange/brown sediment in the syringe.Pre-filled saline syringe was not used and all others in stock were checked and not affected.
 
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Brand Name
N/A
Type of Device
SYRINGE, SALINE, PREFILLED
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
one becton drive
franklin lakes NJ 07417
MDR Report Key7361472
MDR Text Key103170104
Report Number7361472
Device Sequence Number0
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date10/17/2020
Device Model Number306507
Device Catalogue Number306507
Device Lot Number729111C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/20/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer03/20/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/22/2018
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
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