MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	392534
Medical Device Problem Codes	Fluid/Blood Leak (1250); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Initial reporter state: address information was not able to be obtained, therefore, (b)(6) was used as a place holder.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 while using bd insyte¿ autoguard¿ bc shielded iv catheter the catheter separated while retracting and blood splash occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the distributor that there was blood backsplash and the catheter separated when the needle retracted (needle snagging).
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.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 while using bd insyte¿ autoguard¿ bc shielded iv catheter the catheter separated while retracting and blood splash occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the distributor that there was blood backsplash and the catheter separated when the needle retracted (needle snagging).

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12140188
• Report Number: 1710034-2021-00559
• Device Sequence Number: 17156925
• Product Code: FOZ
• UDI-Device Identifier: 00382903925346
• UDI-Public: 00382903925346
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 392534
• Device Lot Number: 9228982
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1