MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	306616
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
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 25x1 rb mck needle pulled out of hub.Verbatim: complaint via email.Email(s) attached.Received the following product complaint.This communication is intended for your quality assurance department.The purpose of this notification is to provide your company with information concerning a customer complaint so that, if necessary, action can be taken to ensure that quality standards are being met.Please investigate and provide, with the outcome/ corrective action for the below listed complaint.Please send an acknowledgement upon receipt of this notification.All investigation results and responses should be sent to it is our goal to close all complaints within 60 days.Complaint number (b)(4).Report date 4/20/2026 factory/manufacturer mfr reorder # (b)(4).Product name needle, sfty 192-n251s preventsg org 25gx1" lot / serial number (b)(6).Product concern just gave a vaccine with the following needle attached, injected all as usual, went to pull it from the patients arm and the needle came completely out of the housing, remaining in the arm.Sample availability please have your qa team look into this and provide a written response regarding the results of the investigation and any corrective and preventive actions.Also, be sure to provide a probable cause if a root cause cannot be identified and inform on previous complaint history.Our goal is to close complaints within 60 days.22-apr-2026: can you please provide an exact date of event in format dd-mmm-yyyy? 20-04-2026 any sample or photo available for investigation? attached packaging and picture of needle on tray after removal how was treatment completed for customer? needle was still out of skin enough to remove gently with my fingers no additional treatment was needed any special surgical intervention needed to remove the device remains from body? no needle was examined and was found to be intact just detached from the hub when removing from patient what was the impact to the patient? patient was already nervous and would not look in the direction of the needle so i did not mention it to him just gently removed it with my hand.There was no lasting impact.

• Brand Name: BD 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: 25101779
• Report Number: 1213809-2026-00238
• Device Sequence Number: 21329758
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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): 05/15/2026

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: 306616
• Device Lot Number: 5093369
• 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: 04/20/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• 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