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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE

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BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE Back to Search Results
Catalog Number 306572
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Swelling (2091)
Event Date 12/16/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8179538. Medical device expiration date: 2021-06-30. Device manufacture date: 2018-06-28. Medical device lot #: 8185572. Medical device expiration date: 2021-06-30. Device manufacture date: 2018-07-04. Medical device lot #: 8242797. Medical device expiration date: 2021-08-31. Device manufacture date: 2018-08-30.
 
Event Description
It was reported that the bd posiflush¿ xs pre-filled flush syringe caused an unspecified number of allergic reactions which included breathlessness and swelling to both legs.
 
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Brand NameBD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE
Type of DeviceSYRINGE
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
8015652341
MDR Report Key8329588
MDR Text Key135851292
Report Number9616657-2019-00121
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306572
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/11/2019 Patient Sequence Number: 1
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