MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON YEL 24GA IV CANNULA; INTRAVASCULAR CATHETER

Catalog Number 391350

Device Problem Material Perforation (2205)

Patient Problem Pain (1994)

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: three photos were received by our quality team for evaluation.From the photos, a defect sample with the cannula pierced through the catheter and a defect sample with peelback on the catheter tip was observed.A device history record could not be evaluated as the lot number is unknown.Based on the returned photo, the probable root cause for could be due to the tubing material.A trend for the peelback issue has been identified for this product line.The appropriate personnel have been notified of this complaint.We have funded a project to examine how to further increase the robustness of the bd neoflon device and prevent future occurrences of this type.The manufacturing process was reviewed.There is a 100% online automated vision system that can detect and reject product that does not meet the lie distance requirement.If the needle pierced through the catheter in the manufacturing process, the defective part would be rejected by the automated vision inspection system as the product will not have any lie distance.The needle pierced through the catheter could be due to the user partially withdrawing the cannula from the catheter and upon reinserting the cannula into the vein, the cannula pierced through the catheter and damages the catheter.As no sample was returned, the root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that bd neoflon yel 24ga iv cannula had a needle through the catheter.The following information was provided by the initial reporter: "tried inserting an iv catheter (neoflon 24 g) but the plastic part of the catheter peeled back.".

• Brand Name: BD NEOFLON YEL 24GA IV CANNULA
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12746468
• MDR Text Key: 279919177
• Report Number: 8041187-2021-00945
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 391350
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• 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