MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD VENLON PRO SAFETY CATHETER; INTERVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Hypersensitivity/Allergic reaction (1907); Phlebitis (2004)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that unspecified bd venlon pro safety catheters experience 2 cases of safety mechanism failure and was involved with 23 cases of infection.It has not been specified whether the serious injury required medical intervention.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.It was reported via post market survey that there were occurrences of localised iv site infections (e.G.Cellulitis, abscess, phlebitis, thrombophlebitis) (23), and the safety mechanism did not activate (2).

• Brand Name: UNSPECIFIED BD VENLON PRO SAFETY CATHETER
• Type of Device: INTERVASCULAR 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11355752
• MDR Text Key: 233246104
• Report Number: 2243072-2021-00459
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 01/25/2021
• 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): Other