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

Catalog Number UNKNOWN

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

Patient Problems Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); Inflammation (1932)

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.Device manufacture date: unknown.Investigation summary: no photograph and no sample received and available for investigation.The retention samples could not be used for investigation as the lot number is unknown.No investigation is possible as there is no sample or lot number reported by the customer.The exact root cause of phlebitis, blood stream infection, iatrogenic, infiltration, leakage, needle clogged, blocked cannot be confirmed due to unavailability of the sample or the lot number.Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A complaint history check was not performed as the lot number is "unknown" for this complaint.A device history record review could not be performed because a model or lot number was not provided by the customer.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Capa is not required at this time.

Event Description

It was reported that unspecified bd" venflon catheter was used and the clinician experienced an infection, phlebitis on 3 occasions, infiltration on 6 occasions, and leakage on 19 occasions.The following information was provided by the initial reporter: it was reported via venflon pmcf survey that the clinician experienced cannula related bloodstream infection (e.G.Blood stream bacteraemia, sepsis),phlebitis, infiltration, extravasation (not related to high pressure injection of contrast media), cannula occlusion, extravasation with high pressure injection of contrast media within the past 2 months.

• Brand Name: UNSPECIFIED BD¿ VENFLON CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12476598
• MDR Text Key: 271570699
• Report Number: 2243072-2021-02324
• 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: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• 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