MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 20G X 1.25 IN; INTRAVASCULAR CATHETER

Catalog Number	383593
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd nexiva diffusics 20g x 1.25 in incomplete flush.The following information was provided by the initial reporter: it was reported by the customer that after troubleshooting issues as much as possible, we decided to take a look at one of the catheters, which is the one in the video and the one i will be sending in for investigation.While hand flushing at 5 ml/sec (2 second flush), 2 of the 3 teardrop-shaped holes were blocked and not allowing saline to exit.I believe this lot of catheters was experiencing pressure limits because of this.Verbatim: several 20g diffusics catheters have been pressuring out at the end of the ct scans.This department has been using 20g diffusics for many years without issue.No other changes to injection pumps, tubing, needless connectors, etc.Scanners are set to 300 psi and ctas flow rates are set to 5 ml/sec.4-5 instances happened within a few days, all with different inserters.Some started in ed, some started in ct by the radiology techs.After troubleshooting issues as much as possible, we decided to take a look at one of the catheters, which is the one in the video and the one i will be sending in for investigation.While hand flushing at 5 ml/sec (2 second flush), 2 of the 3 teardrop-shaped holes were blocked and not allowing saline to exit.I believe this lot of catheters was experiencing pressure limits because of this.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 used and 17 representative samples submitted for evaluation.The reported issue of incomplete flush was not confirmed upon inspection and testing of the samples.Analysis of all the samples showed that there were no abnormalities or damages to the devices.All the representative samples underwent functional testing, and all the samples passed with no defects observed.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.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.
Event or Problem Description
Response received.I need to clarify, i thought the rep took the products with her.No serious injury, however, if product related, caused repeat imaging.(b)(6).The rep has video.

• Brand Name: BD NEXIVA DIFFUSICS 20G 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): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19003872
• Report Number: 9610847-2024-00076
• Device Sequence Number: 9429476
• Product Code: FOZ
• UDI-Device Identifier: 00382903835935
• UDI-Public: (01)00382903835935
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 383593
• Device Lot Number: 1117591
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown