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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER Back to Search Results
Catalog Number 381434
Device Problems Fail-Safe Design Failure (1222); Material Protrusion/Extrusion (2979)
Patient Problem Needle Stick/Puncture (2462)
Event Date 12/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device evaluation: a sample has been received for evaluation. A supplemental report will be filed upon completion of the investigation.
 
Event Description
It was reported that the employee started the iv with the suspect device. When the employee pushed the button to retract the needle, it retracted and then came out the side, resulting in a needle stick injury to the employee's hand.
 
Manufacturer Narrative
The manufacturing site received one used (b)(4) unit with an opened package from the lot number 6061733. The unit consisted of the needle safety barrel assembly. A visual/microscopic examination was performed and it was observed that the needle was fully retracted into the safety barrel and the white button was depressed. The needle was pushed and repositioned to the out position; observed the needle was slightly bent approximately 5/8 of an inch above the needle hub. No needle cover was returned for evaluation. A function test (needle retraction) was performed. The needle was pushed and repositioned to the out position. The button was depressed and the needle retracted fully within the safety barrel. The retraction was successful, meeting no resistance. A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 6061733. There were no reject activity findings throughout the build of this lot that would impact upon the quality of the product. The customer's reported defect was not confirmed as the returned unit did not display any adverse characteristics that would contribute to the defects the customer experienced. There was no definite physical or mechanical evidence that confirmed and supported manufacturing process related issues for the defect observed in this incident. An absolute root cause for this incident cannot be determined.
 
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Brand Name20 G X 1.16 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceSHIELDED IV 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 Key6228267
MDR Text Key64025634
Report Number1710034-2017-00001
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 01/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2019
Device Catalogue Number381434
Device Lot Number6061733
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
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: 01/06/2017 Patient Sequence Number: 1
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