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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 381023
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2017
Event Type  malfunction  
Manufacturer Narrative
Results: bd received one sample unit for evaluation by our quality engineer team. Upon examination, the needle was observed to be partially retracted and damage was found on the grip and at the connection of the grip and the barrel. The needle was repositioned and the button was pressed, the needle retracted unsuccessfully. The defect was determined to have occurred during the manufacturing process. During production, the plug probe and load barrel stations have the ability to become misaligned and produce the type of damage observed. Proper personnel have been notified. A review of the device history record could not be performed as the lot number was not provided. The samples were visually and microscopically evaluated and the customer's indicated failure mode for safety mechanism failure during use was observed. Functional testing was performed. It was observed that when the needle was pushed and repositioned to the out position. The button was depressed and the retraction was unsuccessful. Conclusions: the defect needle retraction failure, as stated in the description of the complaint, was confirmed with the returned unit. The returned unit displayed damage to the grip component. Conclusion: root cause relationship of device to the reported incident: manufacturing. Comment: the plug probe and the load barrel stations in zone 5 have the ability to become misaligned and produce the type of damage observed in the returned sample. When there is a misalignment, the probe inadvertently contacts the edge of the grip and causes the damage observed in the complaint.
 
Manufacturer Narrative
Medical device expiration date: unknown. No lot # provided. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that during use, a bd insyte¿ autoguard¿ bc shielded iv catheter safety mechanism failed to activate. There was no report of injury or medical intervention reported.
 
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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 Key7170138
MDR Text Key266587234
Report Number1710034-2017-00508
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381023
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Yes
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: 01/05/2018 Patient Sequence Number: 1
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