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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
Catalog Number 381411
Device Problems Difficult to Insert (1316); Defective Component (2292); Physical Resistance/Sticking (4012); Device Fell (4014)
Patient Problem No Code Available (3191)
Event Date 04/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the needle slips off hub, also difficult to slide the cannula off needle once inserted, therefore course of treatment changed from iv access to im with a bd insyte-n¿ autoguard¿ shielded iv catheter. The following information was provided by the initial reporter: material no. 381411, batch no. 8275536 (4 of 5). Department: neonatal icu. Product: catheter iv insyte autoguard 24ga x 0. 7 in. Lot number: 8275536. Product expiry date: 30-sep-2021. Number of defective product(s): 4. Is sample available: no. On (b)(6) reported issue was - the insyte was removed from the paper packaging ok, but when removing the cap over the needle/cannula, the entire cannula broke off leaving only an exposed needle. These new insytes are difficult to use as the cannula hub slips off the needle very easily making it difficult to insert, and then is also difficult to slide the cannula off the needle once inserted. The cannula seems to "stick" to the baby's skin and not slide off the needle properly, and this has also led to multiple unsuccessful iv start attempts on babies. Unable to secure iv access, so antibiotics given im instead of iv.
 
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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 Key8659066
MDR Text Key146677240
Report Number1710034-2019-00572
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue Number381411
Device Lot Number8275536
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/02/2018
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: 05/31/2019 Patient Sequence Number: 1
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