MAUDE Adverse Event Report: BECTON DICKINSON SAFETYGLIDE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305916
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle sftygld 25x1 rb safety mechanism broke it was reported by customer that the safety broke off completely, leaving exposed needle rcc received a complaint via email.Incident or problem information mdip reference number (id): 11858 dates of incident (yyyy-mm-dd): (b)(6) 2025 type of incident/problem: a2.Failure (i.E.While preparing for, in use, after use) level of harm: optional report to cmdsnet (health canada): incident details: i immunized client, attempted to flip safety on syringe.Safety broke off completely, leaving exposed needle.I was able to get exposed needle safely to sharps bin without incident.Impact of incident: who was affected? unexpected or prolonged care? yes device information device name/description: needle hypodermic safety 25ga x 1 in manufacturer: becton dickinson canada inc manufacturer code/model: 305916 serial or lot number: (b)(6) expiry date: 2027-09-30 supplier: (b)(4)/catalogue number: 308-305916 is the device retained? yes number of devices: 1 wiped, contained, labelled? unknown device handling hazards (when blank = hazards not specified).
Additional Manufacturer Narrative
Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.Probable root cause.It could be possible that when the hinge was assembled into the needle hub it was pushed down too low inducing the symptom reported by the customer and not detected in the next processes.Verification of the hinge assembly station was performed.Settings were correct.Position of the hinge in the needle hub was correct.

• Brand Name: SAFETYGLIDE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23892566
• Report Number: 2243072-2025-01540
• Device Sequence Number: 12095080
• Product Code: FMI
• UDI-Device Identifier: 00382903059164
• UDI-Public: (01)00382903059164(11)230119(17)270930(10)REGX0369
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

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: 305916
• Device Lot Number: REGX0369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown