MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number 383592

Device Problem Material Discolored (1170)

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

Event Date 10/28/2022

Event Type  malfunction  

Manufacturer Narrative

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 that the bd nexiva¿ diffusics¿ closed iv catheter system experienced discoloration.The following information was provided by the initial reporter: discoloration of the tip of the diffusics catheter.

Manufacturer Narrative

Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of discolored was not confirmed upon inspection of the photo.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Dhr for this lot was reviewed and there are no internal rejects related to the reported issue by the customer.According to the quality records all the inspections of the sampling plan met the acceptance criteria.There are a frequential inspections for the tip quality no failures or extraordinary events were recorded on the dhr.H3 other text : see h10.

Event Description

It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system experienced discoloration.The following information was provided by the initial reporter: discoloration of the tip of the diffusics catheter.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15840582
• MDR Text Key: 307808700
• Report Number: 9610847-2022-00439
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835929
• UDI-Public: (01)30382903835929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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 Model Number: 383592
• Device Catalogue Number: 383592
• Device Lot Number: 2201690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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