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

Catalog Number	305211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.It was reported that the plastic mouthpiece of the transfer needle was broken.Because a physical sample was not returned, a comprehensive evaluation could not be performed.To support the investigation, four photographs were provided for review by the quality team.Two images depict the packaging box, while another shows an opened box containing a vial and filter needle assembly without the packaging blister; the bottom part of the needle hub is visible inside the packaging.The fourth photograph displays the filter needle with the bottom portion of the hub positioned to the side.No additional information could be obtained from these photographs.A device history record review was conducted for material number: 305211, lot: 4081139.The review confirmed that no quality issues were detected during the production of this lot that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections were performed in compliance with specification requirements.Based on the investigation and photographic evidence, the reported issue was confirmed.However, without a physical sample for analysis, it was not possible to determine a probable root cause.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd needle filter blunt fill 18x1-1/2 needle hub was cracked / damaged.The following information was provided by the initial reporter: it was reported that " a t1 distributor of roche reported to hotline that a hospital reported in september and stated that there was an issue with a transfer needle of vabysmos when they used it.After receiving the pictures of complaint sample, it showed the plastic mouth part of the transfer needle was broken." the complaint has been classified as ¿needle ¿ damaged - other¿.Harm to the patient--no.

• Brand Name: BD 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: 23778259
• Report Number: 1911916-2025-00789
• Device Sequence Number: 10083930
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: (01)00382903052110(17)290630(10)4081139
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: 305211
• Device Lot Number: 4081139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown