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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-N AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 381511
Device Problems Break (1069); Leak/Splash (1354)
Patient Problems Infiltration into Tissue (1931); Inflammation (1932); Irritation (1941)
Event Date 08/06/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0085145, medical device expiration date: 2023-02-28, device manufacture date: 2020-03-26, medical device lot #: 0080379, medical device expiration date: 2023-02-28, device manufacture date: 2020-03-24. 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-n¿ autoguard¿ shielded iv catheter was damaged and didn't last as long as normal. Additionally, the catheter caused infiltration and leaking around the top. Lots 0085145 and 0080379 were reported to have been involved in all these events, but it is unknown how many occurrences happened within each lot. The following information was provided by the initial reporter: "the piv is not last as long as normal. We have had some that last 2 hours and some that last 8. We are getting more infiltrates then our typical and leaking around the top of the catheter. " "the weeks of july 12th is when we first started noticing it and it has continued since. " "in the past 2 weeks they have noticed this item and two lot # not lasting like they typically do for their patient needs. Sometimes using 3 pivs/day/patient. ".
 
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Brand NameBD INSYTE-N 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 Key10469427
MDR Text Key205477783
Report Number1710034-2020-00544
Device Sequence Number1
Product Code FOZ
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,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381511
Device Catalogue Number381511
Device Lot NumberSEE SECTION H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated by Manufacturer? No
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: 08/29/2020 Patient Sequence Number: 1
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