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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¿ SHIELDED IV CATHETER INTRAVENOUS CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVENOUS CATHETER Back to Search Results
Catalog Number 381444
Device Problems Fail-Safe Design Failure (1222); Retraction Problem (1536)
Patient Problems Hepatitis (1897); Needle Stick/Puncture (2462)
Event Date 10/26/2017
Event Type  Injury  
Manufacturer Narrative
Results: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined. A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the defect of needle retraction failure. Conclusion: confirmation of the defect stated in the pr could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing. Therefore, there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the defects stated in the pir. This root cause is indeterminate.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 a bd insyte¿ autoguard¿ shielded iv catheter malfunctioned after use. The safety device failed to retract while the nurse was putting the catheter into the sharps container, this resulted in a needle stick injury. The nurse tested (b)(6). It is unknown what medical intervention was given.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceINTRAVENOUS 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
8015652845
MDR Report Key7060317
MDR Text Key250775512
Report Number1710034-2017-00392
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
Type of Report Initial,Followup
Report Date 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number381444
Device Lot Number7192991
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2020
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: 11/27/2017 Patient Sequence Number: 1
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