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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 20GA 1.16IN (1.1 X 30 MM) INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM) INTRAVASCULAR CATHETER Back to Search Results
Model Number 381434
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 05/09/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that a bd insyte¿ autoguard¿ shielded iv catheter 20ga 1. 16in (1. 1 x 30 mm) separated from the hub. The following information was provided by the initial reporter: " it was reported that the catheter broke off while inside the patient. Per customer response: what is the material and/or lot number to the catheter you had issues with? 20g iv, lot #0031666. Can you describe the issue you had with the catheter? the catheter broke off while inside the patient: what is the date of the event? (b)(6) 2020. Did the issue occur before, during or after use? during. Was there serious injury? no. Were there erroneous results? no. Did the course of treatment change? no. Was there exposure to blood/bodily fluid? no exposure, all ppe was used correctly. ¿ was there medical intervention? yes. Were there any other actions taken? yes. The er physician had to cut into the patient to remove the catheter. Are samples available for investigation? yes.
 
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Brand NameBD INSYTE AUTOGUARD SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM)
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 Key10112166
MDR Text Key194776130
Report Number1710034-2020-00347
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903814344
UDI-Public30382903814344
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381434
Device Catalogue Number381434
Device Lot Number0031666
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2020
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: 06/02/2020 Patient Sequence Number: 1
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