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

Catalog Number 381023

Device Problem Material Integrity Problem (2978)

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

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

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 that during use of the bd insyte¿ autoguard¿ bc shielded iv catheter the tubes are not smooth.The following information was provided by the initial reporter: tube forming problem.An issue where catheter tubes are not smooth.

Event Description

It was reported that during use of the bd insyte¿ autoguard¿ bc shielded iv catheter the tubes are not smooth.The following information was provided by the initial reporter: tube forming problem.An issue where catheter tubes are not smooth.

Manufacturer Narrative

Investigation: during dhr review disclosed one non-related qn was initiated on the build of this lot; disposition, root cause and corrective action was applied as per control plan.All other required challenge samples, set-up and in process testing was performed per specifications.Received a 22ga iag catheter-adapter assembly along with a needle cover.The remainder of the assembly was not returned for evaluation.Visual/microscopic evaluation: a white-clear particle speck was observed on the catheter tubing of the assembly received.The particle observed on the catheter tubing was confirmed to be non-foreign (plug shavings) and to have resulted from manufacturing during the assembly process.

• 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: 8474000
• MDR Text Key: 140805012
• Report Number: 1710034-2019-00361
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 381023
• Device Lot Number: 8186618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other