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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 BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 09/07/2020
Event Type  Death  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. 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 bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga 1. 00in was indwelled in a patient when they died. The following information was provided by the initial reporter: "bdj was asked by the customer to investigate whether the product was damaged or not. The details will be reported when additional information becomes available. On 16th sept 2020 new information received. (b)(6) the patient used this product was dead. Date of death is not reported. The customer asked us to perform investigation to see if the product is within specification. No other information is received as of today. 21st sept, 2020 (b)(6). The sales rep received following information. Date of death: (b)(6) 2020. Sex: male. Age: 70s. Primary disease: gastric cancer. History: after endoscopic submucosal dissection is done, the patient suddenly went into cardiopulmonary arrest. Cardiopulmonary resuscitation was done though the patient was dead. ".
 
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Brand NameBD INSYTE AUTOGUARD BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
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 Key10638787
MDR Text Key210162427
Report Number1710034-2020-00646
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
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 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? Yes
Device Operator Other
Device Catalogue Number381023
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2020
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: 10/06/2020 Patient Sequence Number: 1
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