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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH
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BECTON, DICKINSON AND CO. BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306575
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2021
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 100 bd posiflush¿ sp pre-filled flush syringes nacl 0.9% had plungers that were difficult to move during use.The following information was provided by the initial reporter: "it is very stiff when the user pushes the plunger even though it is unsealed.".
 
Event Description
It was reported that 100 bd posiflush¿ sp pre-filled flush syringes nacl 0.9% had plungers that were difficult to move during use.The following information was provided by the initial reporter: "it is very stiff when the user pushes the plunger even though it is unsealed.".
 
Manufacturer Narrative
H.6.Investigation: a device history record review was completed for provided lot number 0189649.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were originally found to be within specification.To aid in the investigation of this issue, three syringes were returned for evaluation by our quality engineer team.The syringes were functionally tested and the plunger movement was found to have resistance.Although an exact cause could not be determined based on the review of the production history records, it is possible that this incident resulted from an error in the silicone distribution process.The silicone station was reviewed in response to this incident.Upon review, a failure was detected with the rejection system.H3 other text: see h.10.
 
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Brand Name
BD POSIFLUSH SP 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 Key11243379
MDR Text Key232277237
Report Number9616657-2021-00014
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 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2023
Device Catalogue Number306575
Device Lot Number0189649
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Date Manufacturer Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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