MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE FILTER 19X1-1/2 TW; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305200
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material #305200 batch #2172517.It was reported by customer that the needle came off of syringe.Rcc received a complaint via email."needle came off of syringe".Lot#: 2172517.19mar2025 - a report was received from astellas safety in the product complaints email box regarding izervay, the report states, "drug was drawn up using sterile technique, during priming, needle came off of syringe and medication ejected from syringe", per the breakage and spoilage replacement form, the serial number is (b)(6).19mar2025 - email notification sent to safety, 19mar2025 - reference the attached reports regarding the lot query and similar defect query, 19mar2025 - per the astellas coc, syringe lots 3027073 and 3027085 were used in izervay kit lot t16240047a, 19mar2025 - investigation request sent to bd for syringe lots 3027073 and 3027085, izervay kit lot t16240047a.20mar2025 - called the eye clinic, spoke to a representative, neither the hcp nor office manager were available, left a message for the office requesting a call back to verify what needle (filter or administration) came off the syringe.20mar2025 - it was determined that since it was unknown what needle came off the syringe, an investigation into the needle component would be submitted, 20mar2025 - investigation request sent to bd for the needle component, lot # 2172517, customer responded on (b)(6).1.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.The product was not administered to the patient.There was no reported harm, injury, complication or negative outcome to the patient or hcp.
Additional Manufacturer Narrative
Pr (b)(4) follow up.It was reported the needle came off the syringe.A device history record review was completed by our quality engineer team for provided material number 305200 and lot number 2172517.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Further action has not been determined necessary at this time.

• Brand Name: NEEDLE FILTER 19X1-1/2 TW
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21710714
• Report Number: 1911916-2025-00248
• Device Sequence Number: 4682315
• Product Code: GAA
• UDI-Device Identifier: 30382903052005
• UDI-Public: (01)30382903052005(11)220920(17)270630(10)2172517
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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): 03/27/2025

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: 305200
• Device Lot Number: 2172517
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown