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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382544
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had foreign matter. No serious injury or medical intervention was reported. Verbatim: "before using the catheter the staff member observed that there was some extra vialon material at the end of the catheter. They then abandoned the cannulation and used another cannula. ".
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8411920
MDR Text Key138651394
Report Number1710034-2019-00281
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K110443
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
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382544
Device Lot NumberUNKNOWN
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 Received02/22/2019
Was Device Evaluated by Manufacturer? Yes
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: 03/12/2019 Patient Sequence Number: 1
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