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	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle sftygld 25x1 rb mck pulled out of the hub.The following information was provided by the initial reporter: material # 306616 batch # 5045756.Rcc received a complaint via email.After administering the injection into the deltoid of a patient, the medical assistant attempted to remove the needle from the arm to put it into sharps.The needle became detached from the luer lock and safety, leaving the needle in the patients arm and the prefilled syringe and luer lock portion of the syringe intact.She was able to remove the needle from the patient.The patient did not experience any adverse events.
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.
Additional Manufacturer Narrative
Pr 13764773 follow up for device evaluation.It was reported the needle became detached from the luer lock and safety.To aid in the investigation, one sample with an opened packaging blister and one photograph was received for evaluation by our quality team.Visual examination of the returned device found the needle absent from the hub.Approximately 300 degrees of the hub orifice circumference was covered with epoxy.The photograph corroborated the condition observed on the sample.No additional defects or imperfections were noted.This condition could occur in the event of a jam at the cannulator.A device history record review was completed for material number 306616, lot 5045756.The review confirmed that all required visual inspections were performed per specification, with no quality notifications related to the reported condition.The lot was inspected and accepted in accordance with the inspection control plan and released for shipment.Device histories for the needle component lots used to manufacture this batch were also reviewed, no documentation of this defect type was identified during the production runs of those lots.To date, no other similar events have been reported for this lot.Based on the investigation, including analysis of the returned sample and the photograph, the customer reported symptom is confirmed.

• 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: 23936956
• Report Number: 1213809-2025-00801
• Device Sequence Number: 13164498
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/27/2026

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: 306616
• Device Lot Number: 5045756
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown