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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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BECTON DICKINSON, S.A. BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306575
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2022
Event Type  malfunction  
Event Description
It was reported while using bd posiflush¿ normal saline syringe the plunger was difficult to press.There was no report of patient impact.The following information was provided by the initial reporter: the syringe containing nacl 10ml can not be injected (iv).
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Investigation summary; as samples were not available for return, ten retained samples were obtained for further evaluation.A silicone distribution test was performed on the retained samples and no issues were identified.A device history record review was completed for provided material number 306575 and lot number 1204195.The review did not reveal any quality notifications related to the reported issue.A second sampling related to dry barrels was performed during the manufacturing process.Although the results of the second sampling were found to be within specifications, it is possible that this incident resulted from an isolated issue with the silicone distribution at the filler machine.Based on the preventive measures in place, we believe this was a unique incident with an unlikely chance of recurrence.H3 other text : see h10.
 
Event Description
It was reported while using bd posiflush¿ normal saline syringe the plunger was difficult to press.There was no report of patient impact.The following information was provided by the initial reporter: the syringe containing nacl 10ml can not be injected (iv).
 
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Brand Name
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13659736
MDR Text Key286742215
Report Number3002682307-2022-00074
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306575
Device Lot Number1204195
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/18/2022
Initial Date FDA Received03/03/2022
Supplement Dates Manufacturer Received06/07/2022
Supplement Dates FDA Received07/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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