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

Catalog Number	305916
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 25x1 rb needle pulled out of hub.Verbatim: complaint via email.We order our bd safety glides through x.But i wanted report defective needles to the company just incase there was a recall l 25gx1inch needles lot 2010821 expiration 12/31/2026 the needle are either closed or too small to push vaccine through lot 4327957 expiration 10/31/2029 the needle disconnected from the connection and stayed in the patient.The patient was not harmed, and the needle was removed from the patients arm, but this could have been terrible if this was a child.The nurses using the needles have many years of experience this was not user error.Both nurses have been giving for 10 plus years.Please let me know what other information you need to identify these defective needles.

• 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: 25472384
• Report Number: 1213809-2026-00303
• Device Sequence Number: 10352801
• Product Code: FMI
• UDI-Device Identifier: 00382903059164
• UDI-Public: (01)00382903059164(10)2010821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• 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: 305916
• Device Lot Number: 4327957
• 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: 05/27/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown