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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD POSIFLUSH; SALINE, VASCULAR ACCESS FLUSH
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BD BD POSIFLUSH; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 306546
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 11/05/2019
Event Type  malfunction  
Event Description
The syringe appears to have black ink or substance smeared on the outside and possibly the inside of the syringe.Device was not used in patient care.Manufacturer response for normal saline flush, bd posiflush (per site reporter).Senior territory manager was made aware.Reported to the hospital to see the device, and would like to take it back for further evaluation at bd.
 
Event Description
The syringe appears to have black ink or substance smeared on the outside and possibly the inside of the syringe.Device was not used in patient care.Manufacturer response for normal saline flush, bd posiflush (per site reporter).Senior territory manager was made aware.Reported to the hospital to see the device, and would like to take it back for further evaluation at bd.
 
Event Description
The syringe appears to have black ink or substance smeared on the outside and possibly the inside of the syringe.Device was not used in patient care.Manufacturer response for normal saline flush, bd posiflush (per site reporter).Senior territory manager was made aware.Reported to the hospital to see the device, and would like to take it back for further evaluation at bd.
 
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Brand Name
BD POSIFLUSH
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BD
5859 farinon dr ste 200
san antonio TX 78249
MDR Report Key9340619
MDR Text Key166973127
Report Number9340619
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup,Followup
Report Date 11/06/2019
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 No Information
Device Model Number306546
Device Catalogue Number306546
Device Lot Number9231020
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2019
Event Location Hospital
Date Report to Manufacturer11/19/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/19/2019
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received12/06/2019
12/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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