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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPERS NEEDLES

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ST PAUL DELTEC GRIPPERS NEEDLES Back to Search Results
Model Number 21-2766-24
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/10/2020
Event Type  malfunction  
Event Description
Information received a implantable ports|deltec gripper plus needles had an exposed needle that would not retract back into the safety arm. This occurred during use, no patient injury occurred or reported.
 
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Brand NameDELTEC
Type of DeviceGRIPPERS NEEDLES
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
7-15-26 fukushima,
minneapolis, MN 55442
MDR Report Key10977870
MDR Text Key220505668
Report Number3012307300-2020-12238
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-2766-24
Device Catalogue Number21-2766-24
Device Lot Number3967853
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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