MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 18X1IN BLUNT FIL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305181
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle 18x1in blunt fill had foreign matter.The following information was provided by the initial reporter: material#: 305181 batch#: unknown.Verbatim: office using the bd 18g blunt needles (305181) to draw are noticing small particles from the plunger inside the vials.List of xxx they are drawing: xxxxxall made by xxxxxxxx all made by xxxxx.They are seeing particles with any of these medications they are drawing.Additional information provided: the have been ongoing and brought to my attention since about 2 months ago i know my ma¿s do a very thorough job at checking all vaccines before drawing up and administering so it happened a few times and then again on the day i contacted mike.There has been no patient harm done because the vaccines were wasted.The lot numbers would probably vary but i know on anything form 2 months to current.I have personally used these needles in a hospital setting for several years and have never heard of this until now with these vaccines.Please advise on what we should do until this gets looked into ?.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: a complaint history check was not performed as the lot number is unknown for this complaint.A device history record review was not performed as the lot number is unknown for this complaint.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.The root cause was not concluded due to unavailability of batch information.
Event or Problem Description
No additional information.

• Brand Name: BD NEEDLE 18X1IN BLUNT FIL
• 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: 23803668
• Report Number: 1911916-2025-00801
• Device Sequence Number: 18489207
• Product Code: GAA
• UDI-Device Identifier: 00382903051816
• UDI-Public: (01)00382903051816
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 305181
• Device Lot Number: UNKNOWN
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown