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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1.00 IN INSYTE¿ AUTOGUARD¿ INTRAVENOUS CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 G X 1.00 IN INSYTE¿ AUTOGUARD¿ INTRAVENOUS CATHETER Back to Search Results
Catalog Number 381523
Device Problems Fluid Leak (1250); Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2017
Event Type  malfunction  
Manufacturer Narrative
Lot analysis: device/batch history record review: yes. Reason: dhr¿s are available for reviews as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable (mdr). Findings: as this complaint was a mdr; -dhr review was performed on the following lot number: 6307826 ¿ the lot number was built on afa line 5, from november 9, 2016 thru november 15, 2016. Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans. Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product. In process samples for needle retraction by button activation were performed on various stages throughout the process, all the inspections passed per specifications. No significant discoveries were found. Visual analysis: observations and testing: received one used iag 22ga unit with an open package from the lot number 6307826. The unit consisted if the retracted needle/barrel assembly and the catheter/adapter assembly. Visual/microscopic examination: observed there was characteristic v shape (cut) of a spear thru in the catheter tubing approximately ¼ of an inch above the nose of the adapter. Water/air leak test: using a lab supplied male slip luer test fitting and the returned extension set performed the leak test. Observed there was no leakage in any are of the connection site. Leakage was observed in the area of the v shape cut. Investigation samples(s) meet manufacturing specifications: no; the returned unit provided for evaluation revealed the character v shape of a spear thru; which did leaked when tested. Comment: it is uncertain whether the defect of needle thru catheter which was observed was caused by manipulation of the device by the user or by the manufacturing process. The unit was returned used, retracted and with an opened package.
 
Manufacturer Narrative
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 during use of the 22 g x 1. 00 in insyte¿ autoguard¿ the catheter had a hole in it causing blood to come out onto patient. There was no report of injury or medical intervention.
 
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Brand Name22 G X 1.00 IN INSYTE¿ AUTOGUARD¿
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 Key6966931
MDR Text Key256282794
Report Number1710034-2017-00268
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number381523
Device Lot Number6307826
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2016
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: 10/20/2017 Patient Sequence Number: 1
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