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

Catalog Number 383517

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 10 bd nexiva¿ closed iv catheter systems had difficult needle disengagement during use.The following information was provided by the initial reporter, translated from german: "we have repeatedly received the information about faulty nexiva's.The cannula cannot be pulled out completely after successful puncture.Thus, the complete system has to be removed again.Patients and users are not satisfied with this issue.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-feb-2023.H6: investigation summary: bd received an unsealed 20 gauge nexiva single port unit from an unknown lot for evaluation.A review of the device history record could not be performed as the reported lot was unknown.Our quality engineer visually inspected the returned unit and observed that the device was already retracted with media present indicating use.The device was reset to its original position and tested for functional retraction.The device retracted successfully with no delay or resistance.Therefore, based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no issues were found with the retraction of this device a definitive root cause could not be determined.

Event Description

It was reported that 10 bd nexiva¿ closed iv catheter systems had difficult needle disengagement during use.The following information was provided by the initial reporter, translated from german: "we have repeatedly received the information about faulty nexiva's.The cannula cannot be pulled out completely after successful puncture.Thus, the complete system has to be removed again.Patients and users are not satisfied with this issue.".

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16251531
• MDR Text Key: 308678592
• Report Number: 1710034-2023-00043
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835171
• UDI-Public: 00382903835171
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183399
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383517
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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