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

Catalog Number 381023

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.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.Device manufacture date: unknown.

Event Description

It was reported that before use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was foreign matter on the catheter tip.

Event Description

It was reported that before use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was foreign matter on the catheter tip.

Manufacturer Narrative

Investigation: a dhr could not be performed as there was no lot# reported.No units or photos were provided for observation and/or testing of this incident therefore the alleged defect was not identified or confirmed and a root cause was not established.Without the actual sample for evaluation and testing there was no physical/mechanical evidence to confirm or support manufacturing process related issues for the defect reported.

• 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: 8411910
• MDR Text Key: 138650959
• Report Number: 1710034-2019-00282
• 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: 04/11/2019

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 Catalogue Number: 381023
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other