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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 383313
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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 when needle release was pulled the needle and wire removed from the device but the safety sheath remained over bung.
 
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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 Key8285837
MDR Text Key134444404
Report Number9610847-2019-00115
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2021
Device Catalogue Number383313
Device Lot Number7208548
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2017
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: 01/29/2019 Patient Sequence Number: 1
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