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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306575
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2021
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 the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% stopper separated from the plunger during the flush.The following information was provided by the initial reporter: "removed 10ml saline flush from pkg and was using it to flush a inter cath when heard a popping noise.Black stopper disengaged from the syringe plunger.1.2 of saline in syringe was given.Unable to give remainder.".
 
Manufacturer Narrative
H.6.Investigation: a device history record review was completed by our quality engineer team for provided material number 306575 and lot number 0337041.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
 
Event Description
It was reported that the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% stopper separated from the plunger during the flush.The following information was provided by the initial reporter: "removed 10ml saline flush from pkg and was using it to flush a inter cath when heard a popping noise.Black stopper disengaged from the syringe plunger.1.2 of saline in syringe was given.Unable to give remainder.".
 
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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)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key11335449
MDR Text Key232845996
Report Number1911916-2021-00124
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 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2023
Device Catalogue Number306575
Device Lot Number0337041
Was Device Available for Evaluation? No
Date Manufacturer Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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