MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 18G X 1.25 IN; INTRAVASCULAR CATHETER

Catalog Number	383594
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva diffusics 18g x 1.25 in had foreign matter it was reported by customer that they visualized brown substance on nexiva diffusics bevel and brownish catheter coloration near laser cut holes.Verbatim: customer analyzed bevel/catheter tips under microscope of autoguard, nexiva sp w/ maxzero, and nexiva diffusics.Concern developed when they visualized brown substance on nexiva diffusics bevel and brownish catheter coloration near laser cut holes.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the 6 samples submitted for evaluation.The reported issue of discolored was confirmed upon inspection of the samples.Analysis of the samples under magnification showed that there were no irregularities with the samples.There was a slight brownish tint near the holes of the catheter at the tip.This slight change in color is normal and is a result of the laser hole cutting process.The amount of browning observed is considered to be within manufacturing specifications and is not a defect.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.Additional batch numbers: 3270886, 3298351, 3270891, 3270878, 3214181, 3236215.Additional batches captured in below prs: 10258288, 10258461.
Event or Problem Description
Customer response on april 23, 2024.Lot numbers as follows: 3076931, 3236215, 3306528, 3270882, 3077239, 3214181, 3270878, 3298351, 3270891, 3270886.

• Brand Name: BD NEXIVA DIFFUSICS 18G X 1.25 IN
• 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): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; colosio no. 579; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19287816
• Report Number: 9610847-2024-00120
• Device Sequence Number: 8740148
• Product Code: FOZ
• UDI-Device Identifier: 00382903835942
• UDI-Public: (01)00382903835942
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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: 03/31/2026
• Device Catalogue Number: 383594
• Device Lot Number: 3076931
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown