MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 18GX2.00IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386809
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause couldn't be determined due to unavailability of sample/batch/lot number information.A complaint history record (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record (dhr) review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable peura doc# (b)(4) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.
Event or Problem Description
It was reported that bd cathena 18gx2.00in winged bc label content missing.Apparently, their delivery got stoppend at their inbound inspection at mediqs warehouse due to missing importer symbol and md (medical device) symbol on label.Customer wanted to get resurance that if this has happened before.No pickup is needed.Contact from this email: (b)(6).Label issue: the package it lacks both importer marking and md (medical device) symbol.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: cathena.Device failure: labeling concerns.

• Brand Name: BD CATHENA 18GX2.00IN WINGED BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21125708
• Report Number: 2243072-2024-01306
• Device Sequence Number: 15161041
• Product Code: FOZ
• UDI-Device Identifier: 00382903868094
• UDI-Public: (01)00382903868094
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K220584
• 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: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 386809
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown