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U.S. Department of Health and Human Services

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

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BECTON DICKINSON UNSPECIFIED BD INSYTE AUTOGUARD CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problems Delivered as Unsterile Product (1421); Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2021
Event Type  malfunction  
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, bd corporate headquarters in (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. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that unspecified bd¿ insyte autoguard had needle retraction issues. The following information was provided by the initial reporter: material no: unknown, batch no: unknown. It was reported that nurses had difficulty using bd insyte autoguard-has increased frequency of failed iv pokes. Verbatim: nurses had difficulty using product. Has increased frequency of failed iv pokes. This is an ongoing issue that several nurses reported simultaneously about the new bd insyte autoguard iv needles. They have previously been using a braun device. Difficult to pierce vessel wall. When pressing button to deploy device, the safety catch shoots away and lands across room. Catheter falls off needle. If nurse forgets to break seal on catheter by rotating 360 degrees prior to use, the seal is extremely difficult to break while needle is in patient and can lead to missing the vein. Indicated that handle is bulky and has increases the number of misses when trying to poke vein (nurse indicates she as missed 3-4 times in a row even with ultrasound guidance, where before they never missed).
 
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Brand NameUNSPECIFIED BD INSYTE AUTOGUARD
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 Key11599782
MDR Text Key268787890
Report Number2243072-2021-00912
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
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 05/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
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 Received05/03/2021
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

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