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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383335
Device Problems Fluid Leak (1250); Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported with the use of the bd saf-t-intima iv catheter safety system there was an issue with damaged tubing resulting in leakage. It was stated by the customer ¿there was a hole in the tubing and blood had leaked during use. There was another product that was observed before use and a hole was identified. There was no injury to the patient. There was no exposure to blood. ¿ there was no report of injury or further medical intervention.
 
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Brand NameBD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7444549
MDR Text Key106042528
Report Number9610847-2018-00110
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2018
Device Catalogue Number383335
Device Lot Number4148785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/19/2018 Patient Sequence Number: 1
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