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

Catalog Number 382544

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/02/2018

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 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.

Event 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.

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.Our quality engineer inspected the returned unit provided by the facility.Bd received one 18ga insyte autoguard unit from lot number 6173926.All components were present and intact.The unit was 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 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.

• 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: 7709448
• MDR Text Key: 114866020
• Report Number: 1710034-2018-00416
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825449
• UDI-Public: 30382903825449
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 382544
• Device Lot Number: 6173926
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other