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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¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382534
Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2017
Event Type  malfunction  
Manufacturer Narrative
Results - bd received one 20ga consisting of a catheter-adapter assembly along with a handwritten note, the needle-barrel assembly was not returned for evaluation. Upon examination, the catheter tubing was slightly curved, there was a v-shape cut in the catheter tubing indicative of needle spear through, and no foreign matter was observed. A device history record review showed no rejected inspections or quality issues during the production of the reported lot numbers that could have contributed to the defects of foreign matter and needle retraction failure. Conclusion - the needle retraction failure could not be confirmed or investigated since the needle assembly was not returned for evaluation. A root cause for this incident could not be determined.
 
Manufacturer Narrative
A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the safety mechanism on a bd insyte¿ autoguard¿ bc shielded iv catheter malfunctioned when activating. It was also reported that upon retraction of needle, there was a piece of plastic noted at the insertion site. There was no report of injury or medical interventions.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC 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
8015652845
MDR Report Key7152653
MDR Text Key250682725
Report Number1710034-2017-00491
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825340
UDI-Public30382903825340
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
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 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2020
Device Catalogue Number382534
Device Lot Number7249714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2017
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: 12/28/2017 Patient Sequence Number: 1
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