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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
Model Number 381823
Device Problems Break (1069); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
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. (b)(4).
 
Event Description
It was reported that the bd insyte autoguard shielded iv catheter experienced catheter tip damage/deformation. The following information was provided by the initial reporter: catheter # 22 is received and when uncapping it is evident that it is broken at the tip of the catheter.
 
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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
8015296192
MDR Report Key11061153
MDR Text Key223768372
Report Number1710034-2020-00816
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903818235
UDI-Public00382903818235
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K952861
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 03/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381823
Device Catalogue Number381823
Device Lot Number0028538
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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