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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 Short Fill (1575)
Patient Problem No Patient Involvement (2645)
Event Date 05/27/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 2 bd posiflush¿ xs pre-filled flush syringes nacl 0.9% had only "half" the amount of sodium chloride solution in them before use.The following information was provided by the initial reporter: "the product only contains half of the sodium chloride in the syringe.".
 
Event Description
It was reported that 2 bd posiflush¿ xs pre-filled flush syringes nacl 0.9% had only "half" the amount of sodium chloride solution in them before use.The following information was provided by the initial reporter: "the product only contains half of the sodium chloride in the syringe".
 
Manufacturer Narrative
Device available for eval?: yes.D.10.Returned to manufacturer on: 6/26/2020.Investigation: a device history record review was performed for provided lot number 0021182 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one physical sample was returned for evaluation by our quality engineer team.The returned syringe was attached to a catheter and was placed within a bag.Within the bag, there was liquid which leaked from the syringe and catheter components.Because of the leakage during transport and/or storage of the sample, a proper evaluation of the reported event could not be completed and the reported complaint could not be verified.
 
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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
MDR Report Key10199652
MDR Text Key203178311
Report Number9616657-2020-00099
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2022
Device Catalogue Number306572
Device Lot Number0021182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2020
Date Manufacturer Received06/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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