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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL IMPLANTABLE PORTS DELTEC GRIPPER

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ST PAUL IMPLANTABLE PORTS DELTEC GRIPPER Back to Search Results
Model Number 19 GAUGE
Device Problem Separation Failure (2547)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Event Description
Information received a smiths medical implantable ports|deltec gripper plus needles malfunctioned. Reported the joint of the needle broke off during removal, thus no function of the safety mechanism possible. No injury occurred.
 
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Brand NameIMPLANTABLE PORTS DELTEC
Type of DeviceGRIPPER
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11690954
MDR Text Key246214546
Report Number3012307300-2021-03288
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/05/2021
Device Model Number19 GAUGE
Device Catalogue Number21-2768-24
Device Lot Number4027302
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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