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

Catalog Number 381044

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

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

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had open packaging leading to the sterile barrier being compromised. No serious injury or medical intervention was reported.

Event Description

It was reported that bd insyte autoguard bc shielded iv catheter had open packaging leading to the sterile barrier being compromised. No serious injury or medical intervention was reported.

Manufacturer Narrative

Our quality engineer inspected the returned units provided by the facility. Bd received two insyte autoguard units from lot number 7019701. The units were received partially open therefore confirming the reported issue. A device history record review showed no non-conformances associated with this issue during the production of this batch. The set-up and in process sample (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak tests were performed on various stages throughout the manufacturing packaging process, all the inspections passed per specifications. The analysis of the top web adhesive where the product characteristics required a specific seal transfer was met per specifications. In addition, the paper top web of the returned units were analyzed under a uv light. The glue used to seal the top and bottom webs was uv fluorescent. This analysis revealed an adequate amount of top web adhesive. The key variables that affected seal strength are seal transfer/width and top web glue. Both variables were looked at during the investigation. The returned unit provided for evaluation for this incident met the manufacturing specification requirements. In conclusion, where the package was found partially opened, the process characteristics that directly influence the seal strength (seal transfer and top web glue), measured within specification. Although the returned unit met specifications, a corrective action project has been implemented to address the issue of inadequate sealing of packages. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 7942838
• MDR Text Key: 123689215
• Report Number: 1710034-2018-00699
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 381044
• Device Lot Number: 7019701
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/08/2018 Patient Sequence Number: 1