MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD SAFETYGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305916
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Follow up.It was reported that during deployment of the syringe safety device, the needle became dislodged from the base.Because no physical sample was returned, a thorough sample evaluation could not be performed.One photograph was provided and reviewed by the quality team.The image shows a needle assembled to an empty syringe, with the safety mechanism holding the needle and the lower portion of the needle outside the hub.No additional defects or imperfections were observed.A device history record review was completed for material number 305916, lot rehz0309.The review identified no deviations associated with the reported condition during manufacturing, packaging, or quality control inspection.All required inspections were completed, and the lot met release criteria.Based on the investigation, including the photographic assessment, the customer reported symptom is confirmed.However, in the absence of the physical sample, a probable root cause could not be determined.
Event or Problem Description
There was no patient harm, injury, complication or negative outcome.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.G.1.Franklin lakes has been listed as the manufacturer.
Event or Problem Description
It was reported that bd needle sftygld 25x1 rb needle pulled out of hub.Verbatim: rcc received a complaint via email.Email(s) attached.Incident or problem information mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2026 site name/location: level of harm: optional report to cmdsnet (health canada): incident details: a child was in for 6 month well child appointment.After administering the hexa vaccine while deploying the safety device on the syringe the needle dislodged from the base causing to separate.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) device expiry date (yyyy-mm-dd): 2027-12-31 supplier: medline (b)(6).Supplier catalogue number: (b)(4).Was the device retained? no.Investigation request expected type of investigation: lot review; report history/trend analysis; clinical contact information primary clinical contact (cc on final report): manager (cc on final report):.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas NJ 88780 ; MX 88780
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24294021
• Report Number: 2243072-2026-00086
• Device Sequence Number: 9408213
• Product Code: FMI
• UDI-Device Identifier: 00382903059164
• UDI-Public: (01)00382903059164(11)240102(17)271231(10)REHZ0309
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2026

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: 305916
• Device Lot Number: REHZ0309
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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