MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381447
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported with the use of the bd insyte autoguard shielded iv catheter there was an issue with the catheter failing to fully retract.
Event or Problem Description
It was reported with the use of the bd insyte¿ autoguard¿ shielded iv catheter there was an issue with the catheter failing to fully retract.
Additional Manufacturer Narrative
Investigation summary: no units or photos were provided for this incident.Dhr review for lot: 7037895 disclosed the following: the lot number was built on afa line 6 from 08feb2017 thru09feb 2017 and packaged on pkg.Line 11 from 11feb2017 thru 13feb2017.All required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Relationship of device to the reported incident: indeterminate - no units or photos were provided for observation and/or testing of this incident therefore the alleged defect was not identified or confirmed and a root cause was not established.Without the actual sample for evaluation and testing there was no physical/mechanical evidence to confirm or support manufacturing process related issues for the defect stated in the pir.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8348674
• Report Number: 1710034-2019-00182
• Device Sequence Number: 11355432
• Product Code: FOZ
• UDI-Device Identifier: 30382903814474
• UDI-Public: 30382903814474
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 381447
• Device Lot Number: 7037895
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other