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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD¿ POSIFLUSH VASCULAR CATHETER FLUSH SYRINGE

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BECTON, DICKINSON AND CO. BD¿ POSIFLUSH VASCULAR CATHETER FLUSH SYRINGE Back to Search Results
Catalog Number 306546
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2018
Event Type  malfunction  
Manufacturer Narrative
The initial reporter also notified the fda on (date) via medwatch # 5081661. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a plunger of bd¿ posiflush was difficult to move during use.
 
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Brand NameBD¿ POSIFLUSH
Type of DeviceVASCULAR CATHETER FLUSH SYRINGE
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer (Section G)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8199975
MDR Text Key132209395
Report Number9616657-2018-00074
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2021
Device Catalogue Number306546
Device Lot Number8192991
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/27/2018 Patient Sequence Number: 1
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