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 BD UNDISCLOSED POSIFLUSH PREFILLED 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 BD UNDISCLOSED POSIFLUSH PREFILLED SYRINGE; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2024
Event Type  malfunction  
Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site is unknown.
 
Event Description
It was reported that bd undisclosed posiflush prefilled syringe leaked.The following information was provided by the initial reporter: clinician experienced: slight leak.No, the complication did not result in harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD UNDISCLOSED POSIFLUSH PREFILLED SYRINGE
Type of Device
SALINE VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18557560
MDR Text Key333501725
Report Number2243072-2024-00051
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/04/2024
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 Health Professional
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/04/2024
Initial Date FDA Received01/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-