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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC GRIPPER

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ST PAUL DELTEC GRIPPER Back to Search Results
Model Number 22 GAUGE
Device Problem Separation Failure (2547)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/18/2021
Event Type  Injury  
Event Description
Information received a smiths medical implantable ports|deltec gripper needle separated and embedded under the skin inside port. The nurse went to access portacath and noticed child was scratching site, swab obtained and redressed. On flushing the portacath it was noticed it was leaking. Nurse asked another member of staff to review. She tried to replace the port needle, however the needle had not came off with the gripper and was left inside skin. The plastic gripper section was reported to coma away. The patient was then transferred to another hospital to have the needle removed under general anesthetic. Needle was successfully removed.
 
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Brand NameDELTEC
Type of DeviceGRIPPER
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
minneapolis, MN 55442
MDR Report Key11720564
MDR Text Key247212256
Report Number3012307300-2021-03425
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K870866
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
Report Date 04/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number22 GAUGE
Device Catalogue Number21-2714-24
Device Lot Number4002612
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/26/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/10/2020
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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