MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA 18GA 1.25IN HF Y; INTRAVASCULAR CATHETER

Catalog Number	383539
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 18ga 1.25in hf y needle through catheter it was reported by customer that needle punctured through the catheter during insertion.Nurse said that it was difficult to remove but was able to get the whole device and catheter out without anything being sheared off.Complaint received via email(s).Needle punctured through the catheter during insertion.Nurse said that it was difficult to remove but was able to get the whole device and catheter out without anything being sheared off.
Event or Problem Description
Material #: 383539; batch#: 4065042.It was reported by customer that needle punctured through the catheter during insertion.Nurse said that it was difficult to remove but was able to get the whole device and catheter out without anything being sheared off.Verbatim: complaint received via email(s) attached.Needle punctured through the catheter during insertion.Nurse said that it was difficult to remove but was able to get the whole device and catheter out without anything being sheared off.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issue of needle through catheter was confirmed upon inspection of the sample.Analysis of the sample showed that the needle had pierced through the catheter near the tip area.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 lot meets our manufacturing specification requirements.The assembly process was reviewed.If the needle pierced through the catheter during the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.The needle can pierce through catheter during product application, when the product was manipulated, or during needle cover removal.Current controls include an outgoing and in-process inspections in place to check for needles that have pierced through the catheter.

• Brand Name: BD NEXIVA 18GA 1.25IN HF Y
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20569396
• Report Number: 2243072-2024-01085
• Device Sequence Number: 12645332
• Product Code: FOZ
• UDI-Device Identifier: 00382903835393
• UDI-Public: (01)00382903835393(11)240305(17)270228(10)4065042
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• 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): 12/03/2024

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 Catalogue Number: 383539
• Device Lot Number: 4065042
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown