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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%; PREFILLED SALINE SYRINGE
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BECTON, DICKINSON AND CO. BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PREFILLED SALINE SYRINGE Back to Search Results
Catalog Number 306572
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2019
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.
 
Event Description
It was reported that an unspecified number of bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced leakage during use.The following information was provided by the initial reporter: pre-filled syringe leaking on induction.Syringe contents leaking under pressure.Minimal consequence apart from the inefficiency of pulsed flushing, risk of occlusion of the central passages or implantable chambers.
 
Manufacturer Narrative
H.6.Investigation summary: a thorough sample investigation could not be completed at this time.If the samples become available, a sample investigation will be completed if determined necessary.A device history record review was performed for lot number 9094918 and the review revealed an intermittent issue with the tip cap torque during the production process.The issue was resolved at this time of occurrence and product was held for inspection.All affected material should have been scrapped.It is possible that there may have been a limited occurrence of this defect outside of the contained material.At this time, further action has not been determined necessary.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.H3 other text : see h.10.
 
Event Description
It was reported that an unspecified number of bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced leakage during use.The following information was provided by the initial reporter: pre-filled syringe leaking on induction.Syringe contents leaking under pressure.Minimal consequence apart from the inefficiency of pulsed flushing, risk of occlusion of the central passages or implantable chambers.
 
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Brand Name
BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
Type of Device
PREFILLED SALINE SYRINGE
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key10348437
MDR Text Key202961849
Report Number9616657-2020-00116
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 09/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2022
Device Catalogue Number306572
Device Lot Number9094918
Was Device Available for Evaluation? No
Date Manufacturer Received07/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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