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

Catalog Number	305196
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
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
White build up on sealed needles, appear to be excess glue.
Additional Manufacturer Narrative
(b)(4) follow up.The complaint described a white buildup on sealed needles that appeared to be excess adhesive.To support the investigation, one photograph was provided for quality evaluation.The image shows a needle assembly without a plastic shield or blister packaging.A droplet of epoxy is visible approximately midway along the length of the needle, and no additional defects or irregularities were identified.This type of condition can occur in the event of a jam at the cannulator.A device history record review was conducted for material number 305196, lot 5268981.The review did not identify any quality issues during the manufacture of this lot that could have contributed to the reported condition.No related quality notifications were found, and all processes and final inspections were performed in accordance with applicable specifications.Verification of the cannulator confirmed that settings were appropriate and product flow was satisfactory.Based on the investigation and the analysis of the submitted photograph, the customers reported observation is confirmed.

• Brand Name: PRECISIONGLIDE
• 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: 24542069
• Report Number: 1911916-2026-00098
• Device Sequence Number: 14868305
• Product Code: FMI
• UDI-Device Identifier: 00382903051960
• UDI-Public: (01)00382903051960(11)250925(17)300930(10)5268981
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 03/11/2026

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: 305196
• Device Lot Number: 5268981
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/08/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown