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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD. INC. PROTECTIV CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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SMITHS MEDICAL ASD. INC. PROTECTIV CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 3060
Device Problem Kinked (1339)
Patient Problem Hematoma (1884)
Event Date 04/04/2018
Event Type  malfunction  
Event Description
When putting an iv on this patient, the iv catheter kinked and the patient had a big hematoma. Rn did it the second time and it happened. According to another nurse it also happened twice the day before. Reported to clinical manager.
 
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Brand NamePROTECTIV
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD. INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7493796
MDR Text Key107587203
Report Number7493796
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 05/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/19/2020
Device Model Number3060
Device Lot Number3548193
Other Device ID NumberGTIN 1035188071187
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/02/2018
Event Location Hospital
Date Report to Manufacturer05/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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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