MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA NEARPORT 18GA X 1.25IN W/ MAXZERO; INTRAVASCULAR CATHETER

Catalog Number	393529
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva nearport 18ga x 1.25in w/ maxzero needle retraction failed.It was reported by customer that iv went in perfectly but when we went to take out the needle it was stuck and would not detach from the iv.We had to take it out and even after it was still stuck.Verbatim #: "we had an instance where an iv went in perfectly but when we went to take out the needle it was stuck and would not detach from the iv.We had to take it out and even after it was still stuck.".
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of needle retraction failure was confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure since no sample was returned for evaluation.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.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.

• Brand Name: BD NEXIVA NEARPORT 18GA X 1.25IN 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: 21286731
• Report Number: 9610847-2025-00009
• Device Sequence Number: 20810451
• Product Code: FOZ
• UDI-Device Identifier: 00382903935291
• UDI-Public: (01)00382903935291(11)240726(17)270630(10)4191986
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/11/2025

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: 393529
• Device Lot Number: 4191986
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown