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	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle sftygld 25x1 rb mck needle pulled out of hub.Verbatim: rcc received a complaint via email.Email(s) attached.This needle came detached from the leuer lock and was in the patient's arm.(b)(6) 2026: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.It was unclear if the patient received the full vaccine or not since the needle came out and some fluid leaked afterwards but it was assumed that they received the majority of the vaccine.No injury noted, rn removed needle that was left in patient's arm.Can you please provide an exact date of event in format dd-mmm-yyyy? 22-12-2025.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle pulled out of hub.One sample and one photo were received.Visual inspection showed that the sample lacked a plastic shield, the needle was separated from the hub, and approximately 40% of the needle outer diameter was covered with epoxy.The reported issue was confirmed through sample analysis, and the photo provided was consistent with the condition of the received sample.A probable root cause is a potential jam at the cannulator that may have created the defect and subsequently went undetected in later processes.Verification of the cannulator was performed, and the equipment settings and product flow were found to be correct.A device history record review was completed for material number 306616, lot 5093367, confirming that all in process and final visual inspections were performed as required, with no quality notifications related to the reported condition.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and complied with applicable product specifications.Complaints received for this device and condition will continue to be tracked and trended, with information documented in monthly trend reports.The business team regularly reviews this data to identify and monitor any emerging trends.
Event or Problem Description
No additional information was provided.

• 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: 24117632
• Report Number: 1213809-2026-00016
• Device Sequence Number: 20330345
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 02/17/2026

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: 5093367
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/19/2026
• 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