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

Catalog Number 382554

Device Problem Device Disinfection Or Sterilization Issue (2909)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported a bd insyte¿ autoguard¿ bc shielded iv catheter had a sterile breach.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: device/batch history record review: dhr review was performed on following lot number: 7076873.The product was manufactured on afa line 9 from march 24, 2017 thru march 25, 2017 and packaged on packaging line 11 from april 5, 2017 thru april 6, 2017.Per review of the dhr¿s it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and 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.Set-up and in-process inspections included but were not limited to blister thickness, bad seal/cut/holes, seal transfer width and package leak test.These were performed on various stages throughout the process, all the inspections passed per specifications.The peura (end user risk analysis): yes.Reason: the peura is required for all mdr reportable investigations.Findings: rm5835 rev 12 version j was analyzed to determine the risk to customer.The analysis showed that current risk is acceptable.Occurrence and severity rankings have not changed.Visual analysis: observations and testing: received one unused iag/bc 16ga unit in partially opened package from the lot number; 7076873.Visual/microscopic examination: the package was partially opened at the both ends of the blister pack.The analysis of top web adhesive: the product characteristics require a minimum of 1/8¿ seal transfer.This characteristic was met.In addition, the paper top web of the returned unit was analyzed.The analysis revealed an adequate of top web adhesive on the bottom web.The key variables that affect the packaging seal are seal transfer/width and top web adhesive presence.Both of these variables were looked at during the investigation.Investigation conclusion: relationship of device to the reported incident: indeterminate.Comment: although the packages were observed to be partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect.

Event Description

It was reported a bd insyte¿ autoguard¿ bc shielded iv catheter had a sterile breach.There was no report of exposure, injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7612392
• MDR Text Key: 111852206
• Report Number: 1710034-2018-00379
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825548
• UDI-Public: 30382903825548
• 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: 08/06/2018

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
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 382554
• Device Lot Number: 7076873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other