MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 25X1 RB MCK; 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	12/12/2025
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 the bd needle sftygld 25x1 rb mck needle pulled out of hub.The following information was provided by the initial reporter: material#: 306616, batch#: 5093369.Verbatim: rcc received a complaint via email.Safety hypodermic needle glide 25g x 1in.(lot # 5093369) while removing the needle after administering the injection the hub broke off the needle.The needle had to be removed separately.Additional information provided: 1.Can you please provide an exact date of the event in format dd-mmm-yyyy? friday 12/12/2025.2.Could you please confirm if there are any samples available to send to bd for investigation? no, we do not, we discarded everything.We just have the pictures that were included.3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No, no harm or injury were happened.When taking the injection out the hub broke off, and the needle stayed in the patient.We were able to successful remove the needle without any harm.
Additional Manufacturer Narrative
(b)(4) supplemental mdr.Needle pulled out of hub.Two photos were provided for evaluation.One photo show two packaging blister top webs, and the other shows a needle assembly with the plastic shield removed.In the second photo, the needle is separated from the needle hub and positioned alongside it.Based on the investigation and review of the photo evidence, the reported condition is confirmed.A device history record review was completed for material number 306616, lot 5093369.All required in process and final visual inspections were performed, and no quality notifications related to the reported condition were identified.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and is in compliance with applicable product specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly, and our business team regularly reviews the collected data to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD NEEDLE SFTYGLD 25X1 RB MCK
• 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: 23957586
• Report Number: 1213809-2025-00806
• Device Sequence Number: 15855692
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 02/03/2026

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: 12/15/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown