MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ VENFLON PRO; CATHETER

Catalog Number UNKNOWN

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

Patient Problems Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); Phlebitis (2004); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.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, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ venflon pro was used and the clinicians experienced an infection on 10 occasions.The following information was provided by the initial reporter: it was reported via post market survey that clinicians encountered cannula related bloodstream infection (e.G.Blood stream bacteraemia, sepsis) (10), phlebitis (70), infiltration (80), extravasation (not related to high pressure injection of contrast media) (80), extravasation with high pressure injection of contrast media (30) and cannula occlusion (102).

• Brand Name: UNSPECIFIED BD¿ VENFLON PRO
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12666738
• MDR Text Key: 277484500
• Report Number: 2243072-2021-02542
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• 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
• Date Manufacturer Received: 09/21/2021
• 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