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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 306582
Device Problem Packaging Problem (3007)
Patient Problem No Information (3190)
Event Date 07/28/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 seal integrity is compromised and inside of packaging has foreign matter with a bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: i would like to inform that, we received saline syringe 10 ml, inside the pack is showing dirt.Pictures received shows the seal of product is compromised.
 
Event Description
It was reported that the seal integrity is compromised and inside of packaging has foreign matter with a bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: i would like to inform that, we received saline syringe 10 ml, inside the pack is showing dirt.Pictures received shows the seal of product is compromised.
 
Manufacturer Narrative
H.6.Investigation summary: a device history record review was performed for provided lot number 9204203 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, two picture samples were returned for evaluation by our quality engineer team.Through examination of the photos, foreign matter was observed on the syringe product packaging.It has been determined that this incident resulted from an abnormality with the waste trim removal pipe of the packaging machinery.An adjustment has been made to the removal pipe to allow a smoother run and proper function.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
SALINE VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key10418258
MDR Text Key204044019
Report Number9616657-2020-00126
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 Received08/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2022
Device Catalogue Number306582
Device Lot Number9204203
Was Device Available for Evaluation? No
Date Manufacturer Received07/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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