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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC; HUBER NEEDLE
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ST PAUL DELTEC; HUBER NEEDLE Back to Search Results
Model Number 21-2939-24
Device Problem Disconnection (1171)
Patient Problems Air Embolism (1697); Ischemia Stroke (4418)
Event Date 10/18/2021
Event Type  Death  
Manufacturer Narrative
Contact phone number: (b)(6).
 
Event Description
Smiths medical received information that on (b)(6) 2021 while using a gripper plus nac, along with a medicon" implantable port, the gripper device was disconnected from the nipro sure plug" mating component.It was reported that air was drawn into the connection part, resulting in an air emboli in the patient.The patient expired on (b)(6) 2021.Cause of death was cerebral infarction.Physician informed that a casual relationship between patient death and the air embolism cannot be denied.No lot number was provided, and the device was discarded by the customer.
 
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Brand Name
DELTEC
Type of Device
HUBER NEEDLE
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key12752756
MDR Text Key280170513
Report Number3012307300-2021-10728
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586016745
UDI-Public10610586016745
Combination Product (y/n)N
PMA/PMN Number
K870866
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number21-2939-24
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/28/2021
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) Death;
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