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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 Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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 discolored/stained primary packaging.It has not been specified whether the product defect was noted prior to, during, or after use.The following information was provided by the initial reporter: our customer complained about brown stains on the packaging.
 
Event Description
It was reported that an unspecified number of bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced discolored/stained primary packaging.It has not been specified whether the product defect was noted prior to, during, or after use.The following information was provided by the initial reporter: our customer complained about brown stains on the packaging.
 
Manufacturer Narrative
Investigation: a device history record review was performed for provided lot number 9255893 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, three picture samples were provided for evaluation by our quality engineer team.Through examination of the pictures, brown stains were observed on the product packaging.It has been determined that these stains resulted from the steam sterilization process.The integrity of the product and the sterile barriers have not been affected.These spots appear only on the outside of the packaging and do not permeate in any way onto the product.Furthermore, microbial permeability testing, cytotoxicity testing, and testing for residual solvents and volatile species has been completed on the packages displaying the brownish stain.The testing confirmed that they do not present any risk to the use of the product and have no impact on the effectiveness, sterility, quality or safety of bd posiflush¿ xs 10ml saline flush syringe.
 
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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 Key10049185
MDR Text Key203803807
Report Number9616657-2020-00075
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 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2022
Device Catalogue Number306572
Device Lot Number9255893
Was Device Available for Evaluation? No
Date Manufacturer Received04/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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