MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON PRO 26GA 0.6MM OD 19MM L; INTRAVASCULAR CATHETER

Catalog Number 391379

Device Problems Leak/Splash (1354); Deformation Due to Compressive Stress (2889); Device Contamination with Chemical or Other Material (2944); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the neoflon pro 26ga 0.6mm od 19mm l catheter tip was damaged, bending/kinking when trying to push it into the vein, or when pulling it out of the vein.Additionally, the needle of one catheter pierced through it after threading it.The following information was provided by the initial reporter: "i think the main problem on the new cannula is that the plastic bit is too soft and it does not advance easily once you have pulled out slightly the metal bit.It bends too easily and i have had a few times the problem that you are in the vein, blood is coming out easily and when you finish taking bloods and try to push the cannula in up to the end before fixing it, it seems to bend inside somehow and it gives high pressures when trying to infuse fluids, although it does not seem to have tissued or anything." "i have seen bended tips when nurses have pulled out a cannula that was giving high pressures in neonates.I have to add to the above and say that i myself is struggling a lot with this new cannula on neonates , i find it too sharp for them.I have couple of incidents where the plastic bit bent even after threading it with the needle as well as the needle puncturing it.".

• Brand Name: NEOFLON PRO 26GA 0.6MM OD 19MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 12304772
• MDR Text Key: 265996303
• Report Number: 8041187-2021-00706
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 391379
• Device Lot Number: 0022226
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2020
• 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