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

Catalog Number	305200
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
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 the customer that ¿needle came off syringe¿ verbatim: rcc received a complaint via email.Email(s) attached.Please initiate a complaint investigation and have it completed within 45-60 days referencing xxx record # (b)(6) for ¿needle came off syringe¿.
Additional Manufacturer Narrative
(b)(6) follow up a report was received indicating that the needle had detached from the syringe.As the physical sample was not returned, a comprehensive evaluation of the product could not be conducted.To support the investigation, two photographs were submitted and reviewed by our quality team.One image depicted a non-bd branded packaging shelf box, while the other showed a syringe placed on an opened box.No additional insights could be derived from the photographs.A review of the device history record (dhr) was completed for the specified material number 305200, lot 2172517.The review found no quality issues during the manufacturing process that could have contributed to the reported condition.Furthermore, there were no associated quality notifications.All manufacturing processes and final inspections were performed in accordance with specification requirements.Based on the investigation and the limited photographic evidence, the reported issue could not be confirmed.In the absence of the physical sample, it is not possible to determine a probable root cause.
Event or Problem Description
Additional information from customer: it has been confirmed that the needle that came off the syringe was a 30-gauge need supplied by the eye clinic and not the filter needle that came with the izervay kit.Please cancel the investigation request for the filter needle ((b)(4)).
Additional Manufacturer Narrative
Follow up mdr for correction.Additional information received, bd product reported was not used.Mfr#: 1911916-2025-00373 is void as a result.

• 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: 22085151
• Report Number: 1911916-2025-00373
• Device Sequence Number: 15180075
• 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: K941562
• 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,Followup
• Report Date (Section B): 06/23/2025

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: 05/22/2025
• Supplement Date Received by Manufacturer: 05/30/2025; Not provided
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 05/30/2025; 06/23/2025
• 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