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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH
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BECTON, DICKINSON AND CO. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306572
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2023
Event Type  malfunction  
Event Description
It was reported that during use with bd posiflush¿ pre-filled saline syringe the stopper separated from the plunger.This is 2 of 2 reports.The following information was provided by the initial reporter, translated from french to english: the clear plastic part of the syringe plunger disengages from the black part of the plunger head.
 
Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: a device history record review was completed for provided material number 306572 and lot number 2256675.The review did reveal one (1) possible non-conformance related to the plunger rod that may have contributed to this reported incident; however, without a physical sample or picture sample, we are unable to confirm this relation.H3 other text : see h10.
 
Event Description
It was reported that during use with bd posiflush¿ pre-filled saline syringe the stopper separated from the plunger.This is 2 of 2 reports.The following information was provided by the initial reporter, translated from french to english: the clear plastic part of the syringe plunger disengages from the black part of the plunger head.
 
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Brand Name
BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
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 Key17318737
MDR Text Key319296101
Report Number9616657-2023-00022
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 09/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306572
Device Lot Number2256675
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2022
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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