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

Catalog Number	305181
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It is reported foreign matter.Description: blunt fill needle was flaking.The white cement that seals the red connector and the needle together was flaking white bits down onto the heparin vial the rn was trying to draw up vial.Some flakes did enter the vial, making it unusable.No patient harm.
Additional Manufacturer Narrative
(b)(4) follow up: the customer reported flaking of the white cement that seals the red connector to the needle.To support the investigation, two photographs were provided.One image shows the top webs of the blister packaging.The second depicts a needle assembly outside its packaging, with the shield removed and placed to the side.In this image, epoxy is visible as a drip toward the top of the needle, and a loose epoxy particle is present inside the plastic shield.No additional defects or imperfections were observed.This condition is consistent with a potential jam at the cannulator.Cannulator verification was performed, settings were within specification and product flow was acceptable.Based on the investigation and photographic analysis, the customer reported symptom is confirmed.
Additional Manufacturer Narrative
Correction: material number updated.See d tab.

• 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: 24428332
• Report Number: 1911916-2026-00079
• Device Sequence Number: 10113681
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: (01)00382903052110
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/17/2026

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: 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: 02/20/2026
• Supplement Date Received by Manufacturer: Not provided; 03/17/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/16/2026; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown