MAUDE Adverse Event Report: BD NEXIVA CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT MAXZERO¿; INTRAVASCULAR CATHETER

Model Number 383552

Device Problem Retraction Problem (1536)

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

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd nexiva closed iv catheter system ¿ single port maxzero¿, the device experienced difficulty with the safety mechanism/ needle disengagement (removal) difficult.The following information was provided by the initial reporter.The customer stated: concern description: guide wire would not disengage from system after insertion.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-09-22 investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one used unit.Visual inspection of the device showed that there was no visible damage to the v-clip or tip shield.Functional testing was performed by attempting to decouple the tip shield from the winged adapter.Decoupling was not possible and the winged adapter could not be rotated, confirming your reported defect.Upon separation of the two components, adhesive residue was found on the outside of the winged adapter and the inside of the tip shield.During manufacturing, adhesive may be incorrectly placed due to adhesive build up or a leak in the dispense system.Preventative maintenance and in process sampling is performed at regular intervals to mitigate the risk from this type of defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported when using the bd nexiva closed iv catheter system ¿ single port maxzero¿, the device experienced difficulty with the safety mechanism/ needle disengagement (removal) difficult.The following information was provided by the initial reporter.The customer stated: concern description: guide wire would not disengage from system after insertion.

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT MAXZERO¿
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12467341
• MDR Text Key: 271262124
• Report Number: 1710034-2021-00802
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835523
• UDI-Public: 30382903835523
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Model Number: 383552
• Device Catalogue Number: 383552
• Device Lot Number: 0010193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2020
• 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