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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. GRIPPER NEEDLE
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SMITHS MEDICAL MD, INC. GRIPPER NEEDLE Back to Search Results
Model Number 21-2947
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Extravasation (1842)
Event Type  Injury  
Event Description
The user facility reported that this device was in use with patient for infusion of medication.During infusion, the user facility reported that the needle became removed from the septum of the portal and caused extravasation in the patient.The user facility reported treatment was used to remove the product infused under the skin and medication was applied to neutralize it.No permanent adverse effect to patient were reported.
 
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
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Brand Name
GRIPPER NEEDLE
Manufacturer (Section D)
SMITHS MEDICAL MD, INC.
st. paul MN
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key3911566
MDR Text Key20656431
Report Number2183502-2014-00447
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K870866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number21-2947
Device Catalogue Number21-2947
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/25/2014
Event Location Hospital
Date Manufacturer Received05/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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