MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO; INTRAVASCULAR CATHETER

Catalog Number	393526
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva nearport 20ga x 1.00in w/ maxzero needle retraction failed.It was reported by customer that customer was unable to remove needle following iv placement.Safety mechanism seemed to jam, and the clinician had to forcefully remove the needle after a few minutes of trouble shooting.Customer was unable to remove needle following iv placement.Safety mechanism seemed to jam, and the clinician had to forcefully remove the needle after a few minutes of trouble shooting.
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
Investigation results: our quality engineer inspected the 1 activated physical sample submitted for evaluation.The reported issue of needle retraction failure was not confirmed upon inspection of the sample.Analysis of the sample showed that the piece was manipulated, exposing the cannula and activating safety system, but there was no damage was observed to the cannula that could be related to the reported failure.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.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.
Event or Problem Description
No additional information.

• Brand Name: BD NEXIVA NEARPORT 20GA X 1.00IN W/ MAXZERO
• 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: 21344964
• Report Number: 9610847-2025-00020
• Device Sequence Number: 15681572
• Product Code: FOZ
• UDI-Device Identifier: 00382903935260
• UDI-Public: (01)00382903935260(11)240923(17)270831(10)4247493
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K231239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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 Catalogue Number: 393526
• Device Lot Number: 4247493
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown