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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 NACL 0.9%; SALINE VASCULAR ACCESS FLUSH
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BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306572
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was only 3ml full when removed from the packaging.The following information was provided by the initial reporter, translated from french: "before draining the syringe the nurse realised that it was only 3ml full.The material was well packaged.".
 
Event Description
It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was only 3ml full when removed from the packaging.The following information was provided by the initial reporter, translated from french: "before draining the syringe the nurse realised that it was only 3ml full.The material was well packaged.".
 
Manufacturer Narrative
After further review, this report was found to be a duplicate of mfr# 9616657-2022-00034.Therefore, this mdr will be cancelled.
 
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Brand Name
BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
Type of Device
SALINE VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer (Section G)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16457860
MDR Text Key310407614
Report Number9616657-2023-00005
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306572
Device Lot Number2166764
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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