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: ST PAUL DELTEC; SET, ADMINISTRATION, INTRAVASCULAR
  • 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
 

ST PAUL DELTEC; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-3465-24
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
It was reported that a smiths medical grippre port was leaking and causing a patient safety risk.No adverse patient effects were reported.
 
Manufacturer Narrative
Other, other text: two samples were received for analysis.The sample was tested with a syringe and the failure mode was able to be replicated.There was a leak in the injection site.Based on the test performed of the one sample returned is confirmed the leak in the p/n 30-2956 "inj.Site, needlefree gripper plus", l/n unknown; it is considerate that root cause is defect to supplier becton dickinson and co; (b)(4) was open 19/feb/2021 to performed analysis of this failure mode.In order to address supplier corrective actions of this failure mode, (b)(4) was issue to supplier on 19/feb/2021.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DELTEC
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11389457
MDR Text Key233946373
Report Number3012307300-2021-01612
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586033049
UDI-Public10610586033049
Combination Product (y/n)N
PMA/PMN Number
K072657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-3465-24
Device Catalogue Number21-3465-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Was the Report Sent to FDA? No
Date Manufacturer Received06/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-