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	02/23/2018
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 during use of the bd insyte¿ autoguard¿ shielded iv catheter ¿the catheter disconnected from the catheter hub.¿ there was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: lot analysis: the lot was built on afa line 6, from may 7, 2017 thru may 9, 2017.Review of the dhr revealed 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.Setup and in process samples for separation catheter from adapter were performed on various stages throughout the process, all the inspections passed per specifications.Visual analysis: observations and testing: received one used iag 18 ga unit from the lot number 7121778.The unit consisted of the retracted needle/safety barrel assembly, adapter and the wedge with the tubing.Visual/microscopic examination: the wedge and tubing had back out of the adapter.Bodily fluids/meds on the wedge and inside of the adapter.Investigation samples(s) meet manufacturing specifications: no, the returned unit provided for evaluation revealed the wedge/tubing had back out of the adapter.Conclusions: the defect separation catheter from adapter; as stated as the reported code was confirmed.A wedge back-out occurs when the depth of the adapter is not swaged sufficiently to maintain the required fit between the wedge and adapter.When the defect occurs, often the wedge and tubing are retracted with the needle into the safety chamber.Root cause: relationship of device to the reported incident: manufacturing.A definitive root cause could not be determined from the sample but the defect would have originated from a manufacturing issue.

• 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: 7322651
• Report Number: 1710034-2018-00094
• Device Sequence Number: 19233899
• Product Code: FOZ
• UDI-Device Identifier: 30382903814474
• UDI-Public: 30382903814474
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 04/30/2020
• Device Catalogue Number: 381447
• Device Lot Number: 7121778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 04/04/2018
• 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