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

Catalog Number	383518
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use with bd nexiva¿ closed iv catheter system leakage occurred at the hub.The following information was provided by the initial reporter: nexiva is leaking at the hub.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-jul-2023.H6: investigation summary: our quality engineer inspected the sample and video submitted for evaluation.Bd received one movie and one 20gx1.75 nexiva catheter adapter assembly from lot number 2300204.The movie provided shows that leakage is occurring under the nose of the catheter adapter.Functional testing was performed on the unit to determine if the same leak is present on the returned unit.Leakage was observed in the same area as in the video.The reported issue was confirmed and determined to be manufacturing related.To further inspect the damage, the catheter adapter was removed from the catheter and evaluated.It was found that the catheter tubing has been pierced leaving a hole that was leading to leakage.This type of damage could happen during the swage process; when the tubing is placed over a pin, it may get pinched or nicked.Misalignment may result in the pin piercing the catheter tubing also.Operators perform sampling for swage depth and flare depth per the quality plan.Additionally, per the quality control plan, inspections for damaged adapter/catheter tubing are performed periodically during the manufacturing process to mitigate the occurrence of this defect.Preventative maintenance (pm¿s) is performed to maintain and ensure proper functioning of equipment.Pm records were verified to be up to date during the production of this lot.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported that during use with bd nexiva¿ closed iv catheter system leakage occurred at the hub.The following information was provided by the initial reporter: nexiva is leaking at the hub.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR 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: ryan reynolds ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17467056
• Report Number: 1710034-2023-00872
• Device Sequence Number: 7135206
• Product Code: FOZ
• UDI-Device Identifier: 00382903835188
• UDI-Public: 00382903835188
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 383518
• Device Lot Number: 2300204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/05/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown