MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SafetyGlide; Needle, Hypodermic, Single Lumen

Catalog Number	305901
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle sftygld 25x5/8 rb needle pulled out of hub.During injection of a 2-month-old baby, needle separated from hub and needle remained in patient's muscle.Patient had a retained partial needle post injection.Safety was not able to be engaged creating another safety concern.First name: (b)(6).Last name: (b)(6).City: (b)(6) serious injury patient had a retained partial needle post injection.Safety was not able to be engaged creating another safety concern.12-jun-2026: here is the requested information: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.Picture available is mentioned as yes, if possible, could you please provide picture samples for investigation? was there a delay of, or change in, the course of treatment due to the event? additional observation and evaluation by pediatrician in a clinic setting and reassurance to parents.

• Brand Name: SafetyGlide
• Common Device Name: Needle, Hypodermic, Single Lumen
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25693112
• Report Number: 1213809-2026-00340
• Device Sequence Number: 13150067
• Product Code: FMI
• UDI-Device Identifier: 00382903059010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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,Followup
• Report Date (Section B): 08/27/2026

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: 305901
• Device Lot Number: 5301004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 07/02/2026; 08/27/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 07/07/2026; 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown