MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 23X1-1/2 RB TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305194
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
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: during use, water would not flow through the needle.Upon removal and inspection, a piece of plastic was found obstructing the lumen.Additional information: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details: no.Total number of occurrences: 1.
Additional Manufacturer Narrative
(b)(4).Follow up: the customer reported that a piece of plastic was found obstructing the lumen.Because the physical sample was not returned, a comprehensive evaluation could not be performed.To support the investigation, the quality team reviewed a single photograph provided by the customer.The image shows the lower portion of the needle hub partially removed from the blister packaging.Material consistent with epoxy appears to be present at the base, however, this cannot be verified from the photograph alone.No separate piece of plastic is visible, and the photograph does not provide additional information to further characterize the condition.A review of the device history record was completed for material number 305194, lot 4081103.The review identified no manufacturing or inspection nonconformances that would be expected to contribute to the reported condition.No related quality notifications were associated with this lot, and all documented processes and final inspections met applicable specification requirements.Based on the available information, the reported condition is confirmed.In the absence of the returned device for physical examination, a probable root cause could not be determined.

• Brand Name: NEEDLE 23X1-1/2 RB TW
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 24209951
• Report Number: 1911916-2026-00044
• Device Sequence Number: 5495097
• Product Code: FMI
• UDI-Device Identifier: 00382903051946
• UDI-Public: (01)00382903051946(11)240321(17)290531(10)4081103
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• 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): 02/02/2026

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: 305194
• Device Lot Number: 4081103
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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