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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 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381533
Device Problem Fail-Safe Design Failure (1222)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2017
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation: a dhr review was performed on the following lot number: 7026719 ¿ the lot number was built on afa line 6, from january 25, 2017 thru january 30, 2017. Per review of the dhr it was concluded that all required challenges samples and testing was performed per specifications s-au33, s-au34, s-au35 and s-au36, 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. Investigation samples(s) were not received for evaluation and testing. Conclusions: the defect of needle retraction failure, as stated in the subject of the pir could not be identified or confirmed and cause could not be determined, as the unit described in the product incident report was not returned for evaluation and testing. Without a unit for evaluation; there was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir. Unable to reproduce the customer¿s experience because units were not returned for evaluation and testing. Root cause: without a sample for evaluation and testing, there was no physical evidence to confirm or support manufacturing process related issues for the reported defect. (b)(4).
 
Event Description
It was reported that the safety on a 20 g x 1. 00 in. (1. 1 mm x 25 mm) bd insyte¿ autoguard¿ shielded iv catheter did not activate. No injury or medical intervention.
 
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Brand Name20 G X 1.00 IN. (1.1 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ 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 Key6828453
MDR Text Key84010657
Report Number1710034-2017-00161
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
Report Date 08/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2019
Device Catalogue Number381533
Device Lot Number7026719
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2017
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: 08/29/2017 Patient Sequence Number: 1
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