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

Catalog Number	305145
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that a hard white substance was present on the outer surface of the needle.To support the investigation, one hundred eight-nine samples were received for evaluation by the quality team.Of these, one hundred eighty-eight samples were received in sealed blister packaging and showed no defects, imperfections, or foreign material.The remaining sample was received in an opened blister and exhibited an epoxy drip on the needle hub.This condition may result if a jam occurs at the cannulator.A device history record (dhr) review was completed for material number 305145, lot 5064152.The review identified no quality issues during production of this lot that could have contributed to the reported condition, and no related quality notifications were found.All processes and final inspections conformed to specification requirements.Verification of the cannulator confirmed correct settings and acceptable product flow.Based on the investigation and the returned-sample analysis, the customer-reported condition was confirmed in one sample.
Event or Problem Description
It is reported foreign matter.Verbatim: hard white substance on outer surface of needle.
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.B3.The date received by manufacturer has been used for this field.

• Brand Name: NEEDLE 23X1 RB
• 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: 24188964
• Report Number: 1911916-2026-00040
• Device Sequence Number: 15831117
• Product Code: FMI
• UDI-Device Identifier: 00382903051458
• UDI-Public: (01)00382903051458
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 305145
• Device Lot Number: 5064152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 01/27/2026
• 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