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

Catalog Number 382533

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 with the use of the bd insyte¿ autoguard¿ bc there was an issue with foreign matter.There was no report of injury or further medical intervention.

Manufacturer Narrative

Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: yes.Investigation summary: received one unused unit in an open package from lot number 7276764.All components were present.The unit was received along with a picture and a note from the customer.Dhr review: the lot number was built on afa line 11, from october 14, 2017 thru october 18, 2017.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 foreign/non-foreign material, particulate loose or embedded were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.The white speck observed on the picture provided by the customer was confirmed to be non-foreign (plug shavings) and to have resulted from manufacturing during the assembly process.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Event Description

It was reported with the use of the bd insyte¿ autoguard¿ bc there was an issue with foreign matter.There was no report of injury or further medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7702850
• MDR Text Key: 114711150
• Report Number: 1710034-2018-00406
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825333
• UDI-Public: 30382903825333
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 382533
• Device Lot Number: 7276764
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other