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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD POSIFLUSH NS FLUSH SYRINGE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BECTON, DICKINSON AND COMPANY BD POSIFLUSH NS FLUSH SYRINGE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 306546
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
Normal saline (ns) dispelled out of syringe via crack visible on the side of the device.
 
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Brand NameBD POSIFLUSH NS FLUSH SYRINGE
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
one becton drive
franklin lakes NJ 07417
MDR Report Key14218370
MDR Text Key290161683
Report Number14218370
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number306546
Device Catalogue Number306546
Device Lot Number2019369
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/11/2022
Event Location Hospital
Date Report to Manufacturer04/27/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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