MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSYTE AUTOGUARD IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/26/2022

Event Type  Injury  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, (b)(4) has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that while using an unspecified bd insyte autoguard iv catheter superficial vein thrombosis occurred.The hematologist placed patient on xarelto.The following information was provided by the initial reporter: post discharge, there are higher iv incidents that causes redness in iv site or superficial vein thrombosis on patients after discharge.Has effected a total of 8 patients from march 2022 to present.Customer is requesting information on trends noticed with this product.Not serious harm or injury but additional testing is required after these incidents.

Manufacturer Narrative

H6: 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.H3 other text : see h10.

Event Description

It was reported that while using an unspecified bd insyte autoguard iv catheter superficial vein thrombosis occurred.The hematologist placed patient on xarelto.The following information was provided by the initial reporter: post discharge, there are higher iv incidents that causes redness in iv site or superficial vein thrombosis on patients after discharge.Has effected a total of 8 patients from march 2022 to present.Customer is requesting information on trends noticed with this product.Not serious harm or injury but additional testing is required after these incidents.

• Brand Name: UNSPECIFIED BD INSYTE AUTOGUARD IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15678853
• MDR Text Key: 302470042
• Report Number: 2243072-2022-01837
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention