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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSYTE AUTOGUARD BC PRO CATHETER

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BECTON DICKINSON UNSPECIFIED BD INSYTE AUTOGUARD BC PRO CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Retraction Problem (1536)
Patient Problems Bacterial Infection (1735); Sepsis (2067)
Event Date 04/13/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. ¿ our business team regularly reviews the collected data for identification of emerging trends. Root cause description: no root cause can be determined as no samples were received.
 
Event Description
It was reported that there was an infection on 8 occasions while using unspecified bd" insyte autoguard bc pro catheter. There were also 10 occurrences of needle retraction issues. The following information was provided by the initial reporter: material no: unknown batch no: unknown. It was reported via post market survey that the clinician encountered bloodstream infection (e. G. Blood stream bacteraemia, sepsis) (8), needlestick injury after use on patient after safety mechanism activation (10) and catheter occlusions (4).
 
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Brand NameUNSPECIFIED BD INSYTE AUTOGUARD BC PRO CATHETER
Type of DeviceCATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11820648
MDR Text Key254640581
Report Number2243072-2021-01455
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
UNKNOWN
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
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
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 Received04/13/2021
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: 05/13/2021 Patient Sequence Number: 1
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