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 383594

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Pain (1994)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

It was reported bd nexiva¿ diffusics¿ closed iv catheter system had a catheter tip that was deformed and discolored.The following information was provided by the initial reporter: "diffusics area of fenestrated tip is enlarged/discolored.".

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 bd nexiva¿ diffusics¿ closed iv catheter system had a catheter tip that was deformed and discolored.The following information was provided by the initial reporter: "diffusics area of fenestrated tip is enlarged/discolored.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the 2 opened and 6 unopened samples submitted for evaluation.The reported issue was not confirmed upon inspection and testing of the samples.The samples were compared to the product specifications and were found to be within the spec.The reported discoloration is from the laser used during production.Sometimes there can be some slight burning of the catheter material from the laser, but a small amount is still considered acceptable per manufacturing specifications.The opened samples also underwent our internal penetration testing and showed no irregularities during the test.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13052493
• MDR Text Key: 285762099
• Report Number: 9610847-2021-00607
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835943
• UDI-Public: 30382903835943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173354
• 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: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 383594
• Device Catalogue Number: 383594
• Device Lot Number: 1015996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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