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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

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NULL CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 02/23/2021
Event Type  malfunction  
Event Description
It was reported that a new iv placed in right upper arm. An hour later iv infiltrated. New iv placed in left hand, heplocked, multiple staff members involved with placing ivs fluid mandatory due to hypotension - multiple mds had to be contacted during middle of the night because of inconsistent iv access. No further adverse patient effects were reported.
 
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Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
Manufacturer (Section G)
NULL
MDR Report Key11742995
MDR Text Key247903590
Report Number3012307300-2021-03562
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 04/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
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 Received03/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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