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: SMITHS MEDICAL GRIPPER PLUS NEEDLE; FPA - 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
 

SMITHS MEDICAL GRIPPER PLUS NEEDLE; FPA - SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-2869
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2014
Event Type  malfunction  
Event Description
User facility reported device was removed from use with pt and user was unable to lock needle into protection device.No adverse effects to pt or user reported.
 
Manufacturer Narrative
The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GRIPPER PLUS NEEDLE
Type of Device
FPA - SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL
st. paul MN
Manufacturer Contact
pete hirte
1265 grey fox road
st. paul, MN 55112
6516287384
MDR Report Key3807635
MDR Text Key4371874
Report Number2183502-2014-00016
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/06/2014
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
Device Expiration Date07/01/2018
Device Model Number21-2869
Device Catalogue Number21-2869
Device Lot Number33X684
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/05/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/06/2014
Distributor Facility Aware Date01/03/2014
Device Age6 MO
Event Location Hospital
Initial Date Manufacturer Received 01/09/2014
Initial Date FDA Received02/06/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
PORT-A-CATH
-
-