MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Model Number 383511

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd nexiva¿ closed iv catheter system experienced a case of damaged tubing clamp, and leakage at the catheter and hub junction.The following information was provided by the initial reporter: the indwelling needle is blocked.The safety clamp is stuck on the steel needle and cannot slide to the middle normally.Blood and fluid leakage were at the root of catheter tube.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 12/13/2021.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one partially retracted needle assembly and two catheter assemblies.Upon initial inspection of the received unit, it was noted that one of the catheters has been damaged at the base and the needle is partially retracted and bent at the notch.Based on what was reported, there are three potential defects: leakage due to damage to the catheter, retraction failure, and an occlusion.First, we tested for leakage.One of the two units received was found to have damage to the catheter tubing at the nose of the winged adapter.Manufacturing caused damage to the tubing may occur during the swedging step, which may create a hole however this was not observed when the two pieces of the tubing were matched.The shape of the damage (the pointy edge in the tubing) may indicate that the needle pierced or cut the catheter.During manufacturing the needle may pierce the catheter wall during the step of mating a needle and a tubing, however this device would be received with the needle pierced through the catheter and could not be used properly.The needle may also pierce the catheter wall during application if the needle is not pulled back in one smooth motion and is instead partially reinserted into the catheter.Further inspection of the needle was performed.The unit arrived with the needle bent at approximately 90 degrees at the notch.It is highly unlikely that such a significant bend was originally present because venipuncture would not be possible (media traces indicate that venipuncture was attempted).Therefore, the bend observed to the needle was likely performed to limit potential needle stick as no sharp¿s container was received.Through our testing, the needle tip was straightened, and the grip was attempted to be retracted.No retraction occurred.A microscopic inspection of the needle was performed to identify any possible causes of the catching on the tip shield.The needle appears to be curved.This curve likely resulted in the needle not retracting through the washer and base of the tip shield.The location of the damage and the needle line up with the needle tip close to the nose of the adapter which could be a potential cause of the damaged catheter as the clinician may have partially reinserted once resistance was felt before attempting further retraction.As we cannot definitively link the catheter and the needle assemblies to the same unit, a root cause could not be determined.The devices were then checked for an occlusion using a bd 10ml syringe.An inability to flush liquid would indicate an occlusion is present.The second catheter assembly (the one without the damaged catheter) was found to be unable to flush.Further inspection identified the occlusion at the connection between the extension tubing and the luer.Microscopic inspection identified the occlusion as adhesive.This defect is likely to occur at the dispense adhesive station when the adhesive is being applied to the outside of the tubing.There is a flow test system down the line that does a 100% inspection for occlusions by blowing air through the system.This vision is challenged and checked per quality documents to ensure the system is working properly.Based on the location and appearance of the occlusion, this step is the most probable root cause of the observed defect.The reported issues were confirmed.A device history record review showed no non-conformances associated with these issues during the production of this batch.

Event Description

It was reported that bd nexiva¿ closed iv catheter system experienced a case of damaged tubing clamp, and leakage at the catheter and hub junction.The following information was provided by the initial reporter: the indwelling needle is blocked.The safety clamp is stuck on the steel needle and cannot slide to the middle normally.Blood and fluid leakage were at the root of catheter tube.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13005596
• MDR Text Key: 285406325
• Report Number: 1710034-2021-01052
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835110
• UDI-Public: 30382903835110
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 383511
• Device Catalogue Number: 383511
• Device Lot Number: 0295533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• 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