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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL SET, ADMINISTRATION, INTRAVASCULAR

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NULL SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Break (1069)
Patient Problem Death (1802)
Event Date 11/01/2020
Event Type  Death  
Event Description
Information was received indicating that a smiths medical catheters were involved in the following situation: a patient underwent 2 catheters, the first was placed subclavium in the surgery room and when the patient was taken to the hemodialysis room, it was bent and had no post-placement flow. Because of the condition of the patient, an attempt was made to place a femoral catheter, and the doctor reports that after insertion, the guide broke. The patient was given several punctures but the catheter never gave flow. Because of the complexity of the patient, they had to be removed from the unit to stabilize. After this the patient died that same day and they could not dialyze her. "obviously the death of said patient was due to various complications that she had".
 
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Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key11041371
MDR Text Key222509992
Report Number3012307300-2020-12572
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2020
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 Unkown

Patient Treatment Data
Date Received: 12/18/2020 Patient Sequence Number: 1
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