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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¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381423
Device Problems Break (1069); Failure to Advance (2524)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/21/2018
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 that a bd insyte¿ autoguard¿ shielded iv catheter would not advance into the patient and the iv broke under the patient's skin. The following was reported, "material no: 381423 batch no: 8253958. It was reported that the iv would not advance into the patient and the iv broke under the patient's skin. Event description per sales rep on sfdc pir states, "iv would not advance into patient. Iv broke under patients skin" (er nurse).
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ 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 Key8400138
MDR Text Key138383198
Report Number1710034-2019-00266
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number381423
Device Lot Number8253958
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 Received02/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2018
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: 03/07/2019 Patient Sequence Number: 1
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