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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PROTECT IV PLUS SAFETY IV CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

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SMITHS MEDICAL ASD, INC. PROTECT IV PLUS SAFETY IV CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM Back to Search Results
Model Number 24 GAUGE
Device Problems Bent (1059); Failure to Advance (2524)
Patient Problem Hypoglycemia (1912)
Event Date 04/13/2016
Event Type  malfunction  
Event Description
Rn was trying to start an iv on a newborn being admitted to the nicu for hypoglycemia and when the nurse removed the catheter because she couldn't get it to advance, the plastic tip was bent and almost sheared off.
 
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Brand NamePROTECT IV PLUS SAFETY IV CATHETER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen street
southington CT 06489
MDR Report Key5596971
MDR Text Key43324763
Report Number5596971
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2016
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24 GAUGE
Device Catalogue Number3063
Device Lot NumberST3142417
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer04/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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