MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 23X1 RB MCK; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	306610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
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 23x1 rb mck needle pulled out of hub.Verbatim: rcc received a complaint via email.Email(s) attached.A licensed practical nurse (lpn) prepared a vaccination using the same type of needle, a 23g x 1"" needle with lot number 5304527.The lpn administered the vaccine as intended.When withdrawing the syringe from the patient, the needle disengaged from the luer-lock connection and remained suspended within the safety mechanism in an unsecured manner.This created a potential needle-stick hazard for the lpn.To mitigate risk and allow for further evaluation, the device was set aside for management review and documentation.After a photograph was taken for reference, the needle was safely disposed of in the sharps container in accordance with established safety procedures." additional information was received on january 26th 2026.Was the needle removed completely by the lpn and did it appear to be intact? the needle was removed completely by the medical assistant and she did report that it was intact.Did the patient have to have any imaging or further follow up? the patient did not have any further imaging or follow-up.Did the patient experience any discomfort after needle was removed? the patient did not have any discomfort after the needle was removed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle pulled out of hub.One photo was provided showing a syringe with a needle assembly that includes a safety mechanism but is missing the needle.Based on the investigation and review of the photo, the reported symptom is confirmed.However, because an actual product sample was not available for analysis, a probable root cause could not be determined.A device history record review was completed for material number 306610, lot 5304527.All in process and final visual inspections were performed as required, 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 the applicable product specifications.Complaints received for this device and reported condition will continue to be tracked and trended.This information will be captured in monthly trend reports and monitored for any emerging patterns by our business team.
Event or Problem Description
No additional information was provided.

• Brand Name: BD NEEDLE SFTYGLD 23X1 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: 24202712
• Report Number: 1213809-2026-00034
• Device Sequence Number: 9635506
• Product Code: FMI
• UDI-Device Identifier: 10612479262536
• UDI-Public: (01)10612479262536
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 02/18/2026

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: 306610
• Device Lot Number: 5304527
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2025
• 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