MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT WITH MAXZERO; INTRAVASCULAR CATHETER

Catalog Number	383558
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd nexiva single port with maxzero experienced needle disengagement difficulty.This is 1 of 2 events.The following information was provided by the initial reporter: this past weekend, we had another iv, same lot number, do the same thing as described below.They couldn't get the needle inside the nexiva catheter out after placing the device.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 24-apr-2023 investigation summary bd received an unsealed 20 gauge nexiva unit from lot 2308968 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and attempted to decouple the device.The device decoupled successfully but there was some resistance felt.Next, the device was microscopically inspected some damage or debris was found in the washer and needle.Finally, the device was dissected and measured to determine if the device was within product specifications.The device was found to be acceptable and within specifications.Therefore, based off the resistance felt when decoupling the device the engineer was able to verify the reported defect.It was determined that the debris or damage observed during inspection was the cause of the resistance felt.However, the engineer was unable to identify the origin of this debris as the device was returned unsealed.
Event or Problem Description
It was reported that the bd nexiva single port with maxzero experienced needle disengagement difficulty.This is 1 of 2 events.The following information was provided by the initial reporter: this past weekend, we had another iv, same lot number, do the same thing as described below.They couldn't get the needle inside the nexiva catheter out after placing the device.

• Brand Name: BD NEXIVA SINGLE PORT WITH MAXZERO
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16864772
• Report Number: 1710034-2023-00470
• Device Sequence Number: 17628417
• Product Code: FOZ
• UDI-Device Identifier: 00382903835584
• UDI-Public: (01)00382903835584
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K170336
• 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): 06/06/2023

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: 383558
• Device Lot Number: 2308968
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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