MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 20 GA X 1 IN SINGLE PORT; PERIPHERAL IV CATHETERS

Catalog Number 383516

Device Problems Backflow (1064); Improper Flow or Infusion (2954)

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

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd nexiva 20 ga x 1 in single port back-flowed.The following information was provided by the initial reporter, translated from chinese to english.After puncturing the patient's body, when the needle core is pulled out, blood returns to the isolation plug behind it.

Event Description

It was reported that bd nexiva 20 ga x 1 in single port back-flowed.The following information was provided by the initial reporter, translated from chinese to english.After puncturing the patient's body, when the needle core is pulled out, blood returns to the isolation plug behind it.

Manufacturer Narrative

Investigation results: our quality engineer inspected the photographs submitted for evaluation.Bd received three photos of a 20ga x 1.00in.Single port nexiva unit.The photos display media in the unit and extension tubing of the device with a syringe connected to it.The visual inspection discovered blood leaking at the bottom of the adapter.Blood appears to be passing through the septum.The reported issue was confirmed as leakage at the septum.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the assembly of the secondary septum.It may be possible for the septum to not be fully seated or damaged due to a machine misalignment.This would be unlikely to occur in the clinical environment.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD NEXIVA 20 GA X 1 IN SINGLE PORT
• Type of Device: PERIPHERAL IV CATHETERS
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17858152
• MDR Text Key: 324779167
• Report Number: 1710034-2023-01150
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: (01)30382903835165
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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
• Device Operator: Other
• Device Catalogue Number: 383516
• Device Lot Number: 2312192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• 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