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

Catalog Number 381023

Device Problem Microbial Contamination of Device (2303)

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

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 shielded iv catheter there was an issue with foreign matter and mold.

Manufacturer Narrative

Investigation summary: dhr-the lot number was built / packaged on afa line 12 from 19april2018 thru 22april2018.Review disclosed one non-related qn ((b)(4)-cooling water oos) was initiated during the build of this lot, disposition, corrective action and root cause were applied per quality control plan all other challenge, set-up and in process samples were performed and all passed per specifications.Received 44 iag bc 22ga packages within a dispenser from lot 8107798.All of the contents within were intact.Visual/microscopic evaluation: 3 of the units received had traces of soiled packaging trim caught on the seal of the packages.The remainder of the packages did not reveal any fm related defects.Ftir test was performed (franklin lakes) confirming the material observed is lubrication used on the machines as part of preventive maintenance.Manufacturing ¿ packaging: the packaging trim was not removed by the removal vacuum.If the package trim is not removed it goes around the machine coming into contact with pm lube and continues around into the seal.

Event Description

It was reported with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was an issue with foreign matter and mold.

• 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: 8116862
• MDR Text Key: 128888777
• Report Number: 1710034-2018-00858
• 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: 01/04/2019

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: 03/31/2021
• Device Catalogue Number: 381023
• Device Lot Number: 8107798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other