Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON, DICKINSON AND CO. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306572
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2022
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.
 
Event Description
It was reported that 12 bd posiflush¿ pre-filled saline syringe experienced plunger movement difficult.The following information was provided by the initial reporter: several nurses reported that they were unable to empty the syringe because of the overpressure.
 
Manufacturer Narrative
A device history record review was completed for provided material number 306572 and lot number 2249292.The review did not reveal any non-conformances during the production process which could have contributed to the reported incident.As samples were unavailable, our quality team was unable to perform a sample investigation.H3 other text : see h10.
 
Event Description
It was reported that 12 bd posiflush¿ pre-filled saline syringe experienced plunger movement difficult.The following information was provided by the initial reporter: several nurses reported that they were unable to empty the syringe because of the overpressure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer (Section G)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16016798
MDR Text Key308261558
Report Number9616657-2022-00050
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeFR
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 01/04/2023
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 Number306572
Device Lot Number2249292
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/01/2022
Initial Date FDA Received12/20/2022
Supplement Dates Manufacturer Received01/04/2023
Supplement Dates FDA Received01/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-