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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 381433
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Phlebitis (2004); Thrombosis (2100)
Event Date 01/04/2019
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided. This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences. Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place. A device history record could not be completed as no lot number was received. Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter was inserted into the patient on (b)(6) 2019, resulting in "phlebitis, thrombophlebitis, or dvt" after use when the catheter was removed the next day. However, no further information was provided by the initial reporter. This complaint was created to capture the 1st of 10 related incidents. The following information was provided by the initial reporter: health professional called and stated facility has had 10 reports of phlebitis, thrombo phlebitis or dvt since (b)(6). Has the dates that patients had the iv's inserted: on (b)(6) 2019, removed (b)(6) 2019. Inserted (b)(6) 2019, removed (b)(6) 2019. On (b)(6) 2019, inserted and removed. Inserted (b)(6) 2019, removed (b)(6) 2019. On (b)(6) 2019, inserted and removed. Inserted (b)(6) 2019, removed (b)(6) 2019. Inserted and removed (b)(6) 2019. Inserted (b)(6) 2019, removed (b)(6) 2019. Inserted and removed (b)(6). Inserted (b)(6) 2019 and removed (b)(6) 2019.
 
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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 Key8846622
MDR Text Key152920763
Report Number1710034-2019-00817
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903814337
UDI-Public30382903814337
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
Report Date 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number381433
Device Lot NumberUNKNOWN
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 Received07/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/31/2019 Patient Sequence Number: 1
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