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
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system experienced discoloration.The following information was provided by the initial reporter: catheter, tip is discolored.
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
G5: corrected 510k number k123734 to k173354 h6: investigation summary our quality engineer inspected the 2 representative samples submitted for evaluation.The reported issue of discoloration was confirmed upon inspection of the samples.Both samples were visually inspected, and one of the two samples showed discoloration.Bd determined that the cause of the discoloration can be associated to our laser cutting process during manufacturing.The discoloration is slight burning of the material due to the heat from the cutting laser.However, the amount of discoloration found was acceptable based off our manufacturing standards.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
It was reported that the bd nexiva¿ diffusics¿ closed iv catheter system experienced discoloration.The following information was provided by the initial reporter: catheter, tip is discolored.

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM
• Common Device Name: 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: 15090052
• Report Number: 9610847-2022-00271
• Device Sequence Number: 14742764
• Product Code: FOZ
• UDI-Device Identifier: 30382903835929
• UDI-Public: 30382903835929
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• 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): 08/09/2022

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2025
• Device Model Number: 383592
• Device Catalogue Number: 383592
• Device Lot Number: 2090066
• 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: 06/23/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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