MAUDE Adverse Event Report: BD SUZHOU (MDS) BD NEXIVA 20GA 1.25IN HF Y; INTRAVASCULAR CATHETER

Catalog Number	383537
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of catheter broke/ separated after placement was confirmed upon inspection of the photos.However, bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.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.
Additional Manufacturer Narrative
A code updated to a0401.
Event or Problem Description
None reported.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and samples submitted for evaluation.The reported issue of catheter broke/ separated after placement was not confirmed upon inspection of the sample.Analysis of the sample showed no catheter tubing on the used sample.The unused sample was subjected to a catheter adapter pull test and no abnormalities were observed.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.The actual returned sample had broken catheter tubing and jagged marks.Per the verbatim, the actual sample had been removed by the nurse from the patient, and the technique of removal could have broken the catheter.The nexiva manufacturing process was reviewed, there is no change in the process that could cause the catheter tubing damage.The root cause could be attributed to user technique for removal of the catheter tubing; however it cannot be confirmed.

• Brand Name: BD NEXIVA 20GA 1.25IN HF Y
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21911520
• Report Number: 2243072-2025-00575
• Device Sequence Number: 21112508
• Product Code: FOZ
• UDI-Device Identifier: 00382903835379
• UDI-Public: (01)00382903835379(11)241204(17)271130(10)4333226
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Followup,Followup,Followup
• Report Date (Section B): 05/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 383537
• Device Lot Number: 4333226
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/30/2025; Not provided; 05/27/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/01/2025; 05/05/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown