MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD CANNULA BLUNT PLASTIC; NEEDLE

Catalog Number	303345
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd cannula blunt plastic needle was coring.The following information was provided by the initial reporter: "needle coring, customer called in wanting safety data regarding coring of blunt needle, did not want to file a complaint." advised customer that this is a complaint and reportable issue."customer was not being cooperative and refused to provide the facility name.".
Additional Manufacturer Narrative
B:3.The date received by manufacturer has been used for this field.E:1.Address was not located and il was used.H:3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD CANNULA BLUNT PLASTIC
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18451530
• Report Number: 1911916-2023-00930
• Device Sequence Number: 7780804
• Product Code: FMI
• UDI-Device Identifier: 30382903033455
• UDI-Public: (01)30382903033455
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• 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
• Report Date (Section B): 12/20/2023

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: Other
• Device Catalogue Number: 303345
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown