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

Catalog Number	305106
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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 a crack on the needle hub, causing leak.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.The customer reported leakage through a crack in the needle hub.To support the investigation, one sample without a blister package and two photographs were provided and evaluated by the quality team.Visual inspection identified a pin sized hole located 9 32 inch from the base of the needle hub.The sample was assembled to a syringe filled with saline, and leakage from the hole was replicated.The photographs correspond to the sample received.No additional defects or imperfections were observed.This condition could occur during the molding process if an imperfection were present in the molding tool.A device history record review was completed for material number 305106, lot 4081033.The review did not reveal any quality issues during production that could have contributed to the reported condition, and there were no related quality notifications.All processes and final inspections were performed in accordance with specification requirements.The sample will be shared with associates for awareness.Based on the investigation, including analysis of the returned sample, the customers reported symptom 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: 24597970
• Report Number: 1911916-2026-00114
• Device Sequence Number: 9561494
• Product Code: FMI
• UDI-Device Identifier: 00382903051069
• UDI-Public: (01)00382903051069(17)290531(10)4081033
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/02/2026

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: 305106
• Device Lot Number: 4081033
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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