MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE FILTER BLUNT FILL 18X1-1/2; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305211
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
"when we took out the blunt fill needle from the faricimab box, found the packaging of the blunt fill needle was unsealed." the needle was not used for the patient.
Additional Manufacturer Narrative
H3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.B3: the date received by manufacturer has been used for this field.B3: the date received by manufacturer has been used for this field.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.

• Brand Name: NEEDLE FILTER BLUNT FILL 18X1-1/2
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 24345056
• Report Number: 1911916-2026-00067
• Device Sequence Number: 9912129
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: (01)00382903052110(17)290930(10)4212641
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 305211
• Device Lot Number: 4212641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown