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

Catalog Number	305180
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
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: product concern ticket number: (b)(4).Date of incident: (b)(6) 2026.Concern description: defective unidentified hard, thick white substance in the needle (sealed package).Occurrences: 1 each.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that a hard, thick white substance was present in the needle.To support the investigation, one sample in opened blister packaging was received and evaluated by the quality team.A visual inspection was performed, which identified an epoxy drip over the needle hub.No additional defects or abnormalities were observed.This condition may occur in the event of a jam at the cannulator.A device history record review was conducted for material number 305180, lot 5064188.The review did not identify any quality issues during production that could have contributed to the reported condition, and no related quality notifications were found.All manufacturing processes and final inspections met specification requirements.Verification of the cannulator confirmed that the settings were correct and that product flow was normal.Based on the investigation and analysis of the returned sample, the customer reported condition is confirmed.

• Brand Name: NEEDLE 18X1-1/2 BLUNT FILL
• 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: 24210467
• Report Number: 1911916-2026-00046
• Device Sequence Number: 9653756
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: (01)00382903051809(11)250305(17)300430(10)5064188
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2026

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: 305180
• Device Lot Number: 5064188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown