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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 08/04/2020
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone #: (b)(6).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 the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: material no.306572, batch no.0044501.Event description: black debris in the tip of the syringe noted after cap removed.
 
Event Description
It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: material no.306572, batch no.0044501.Event description: black debris in the tip of the syringe noted after cap removed.
 
Manufacturer Narrative
H.6.Investigation summary: a device history record review was performed for provided lot number 0044501 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 picture sample was returned for evaluation by our quality engineer team.Through examination of the picture, foreign matter was observed on the tips of the syringes.It has been determined that this incident may be associated with the molding machinery.Through further examination of the manufacturing process, burn marks were found on the tip caps manufactured in the molding machine.The cavity of the molding machine was cleaned and polished to prevent this defect from recurring.Further action has not been determined at this time.Our quality team will continue to closely monitor the production process for signs of this potential defect and any emerging trends.H3 other text: see h.10.
 
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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 Key10451641
MDR Text Key205291647
Report Number9616657-2020-00131
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 distributor,foreign,other
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 Received08/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2023
Device Catalogue Number306572
Device Lot Number0044501
Was Device Available for Evaluation? No
Date Manufacturer Received08/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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