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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the needle immediately broke off the hub.Verbatim: i was using a blunt fill needle to draw up a medication, when i stuck the needle into the rubber stopper of the vial, the needle immediately broke off the hub.I removed it and proceeded to use a different needle to draw up medication.Was there injury? no.
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.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported that the needle detached from the hub.One sample with an opened blister package was received for evaluation by the quality team.Visual inspection confirmed the needle was separated from the hub and has approximately 50 percent of the necessary epoxy.No other defects or imperfections were observed.This condition could occur during assembly in the event of a cannulator misfeed.A device history record review was completed for material number 305180, lot 5177539.The review did not identify any quality issues during production that could have contributed to the reported condition, and no related quality notifications were issued.All processes and final inspections met specification requirements.Cannulator verification confirmed that the settings were correct and product flow was acceptable.To date, no other similar events have been reported for this lot.Based on the investigation, including returned sample analysis, the customer reported symptom 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: 24118132
• Report Number: 1911916-2026-00021
• Device Sequence Number: 14949234
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: (01)00382903051809(11)250626(17)300630(10)5177539
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 01/29/2026

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: 5177539
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown