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

Catalog Number	382554
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheters packaging adhesive failed, resulting in a sterility breach.Noticed before use.There was no report of exposure, injury, or medical intervention noted.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 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.Our quality engineer inspected the returned units provided by your facility.Bd received one insyte autoguard unit from lot number 6119789.All components were present and intact.The unit was received partially open therefore confirming your 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 samples (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 require 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 is uv fluorescent.This analysis revealed an adequate amount of top web adhesive.The key variables that affect 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.
Event or Problem Description
It was reported that the bd insyte autoguard bc shielded iv catheters packaging adhesive failed, resulting in a sterility breach.Noticed before use.There was no report of exposure, injury, or medical intervention noted.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7707105
• Report Number: 1710034-2018-00425
• Device Sequence Number: 14146056
• Product Code: FOZ
• UDI-Device Identifier: 30382903825548
• UDI-Public: 30382903825548
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: 04/30/2019
• Device Catalogue Number: 382554
• Device Lot Number: 6119789
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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