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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, 20G X 1.16 IN. INTRAVENOUS CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC, 20G X 1.16 IN. INTRAVENOUS CATHETER Back to Search Results
Catalog Number 381034
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Phlebitis (2004)
Event Date 11/09/2015
Event Type  Injury  
Manufacturer Narrative
(b)(6). Device evaluation: result - a review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5062943. Two representative units in sealed packaging from the lot number 5062943 were received. Package leak testing was performed using a lab supplied iso 22ga needle/hub assembly attached to the male luer fitting of the station. The leak test was performed by submerging the packages beneath the water line; piecing the needle/hub into the cavity; many bubbles were released from many locations of the package. There were no gross leaks or opened seals. A visual/microscopic examination was performed and there was no foreign matter observed on any the units. The bevel area had the proper bevel cut and the secondary bevel was present. The lie distance was within acceptable range. The cannula tip quality was found to be acceptable. No bends holes, kinks splits or wrinkles were found in the catheter tubing. The catheter tip quality was found to be acceptable. The representative units tested met all specification requirements. The finished product testing report was reviewed and all pallets passed. The pyrogen samples also passed all testing. Conclusions - the defect was not confirmed. There was no physical evidence to confirm or to support manufacturing process related issues for the defect. The returned units did not display any adverse characteristics that would contribute to the defect the customer complained about. The defects described in the incident report could not be confirmed or replicated with the returned units.
 
Event Description
It was reported that in recent weeks, the pneumology department noticed an increase in the appearance of thrombophlebitis from the suspect device. Echo doppler was performed to refine the diagnosis. The patient experienced significant pain and was provided anticoagulant treatment. Another department was contacted and it was reported that they were also experiencing thrombophlebitis. No additional specific patient information was provided, including the number of patients involved.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC, 20G X 1.16 IN.
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 Key5345664
MDR Text Key35164940
Report Number1710034-2016-00002
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 01/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date03/31/2018
Device Catalogue Number381034
Device Lot Number5062943
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 Received12/14/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/05/2016 Patient Sequence Number: 1
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