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

Catalog Number	305916
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
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 25x1 rb -safety mechanism broke.Rcc received a complaint via email.Incident or problem information incident details: after administering vaccine to client, writer attempted to deploy the safety mechanism on the needle.Safety came detached from needle and flew into adjacent wall where it came to rest on the floor.Writer disposed of used needle as it was contaminated, was unsure of whether safety mechanism touched needle so enclosed in an alcohol wipe and wrapper and brought back to chc where it was placed into a plastic container and stored in desk.Impact of incident: who was affected? patient unexpected or prolonged care? yes frequency of problem: first time.Device information device name/description: needle hypodermic safety 25ga x 1 in.Manufacturer code/model: 305916 serial or lot number: not provided expiry date: supplier/catalogue number: 308-305916 is the device retained? yes number of devices: 1 wiped, contained, labelled? wiped, double bagged (if consumable), and labelled as per instructions.Device handling hazards (when blank = hazards not specified) blood and/or body fluid contaminated.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - safety mechanism broke.One sample was received, consisting of the top portion of a safety mechanism.A visual inspection was performed, and no damage or imperfections were observed.Based on the investigation and analysis of the sample, the reported symptom is confirmed.However, without the remaining components of the actual sample for evaluation, a probable root cause could not be determined.The lot number is unknown; therefore, a device history record (dhr) review or quality notification (qn) review could not be performed.Complaints received for this device and the reported condition will continue to be tracked and trended.This information will be included in monthly trend reports and monitored for emerging patterns by our business team.
Event or Problem Description
No additional information was provided.

• Brand Name: SAFETYGLIDE
• 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: 24179831
• Report Number: 1213809-2026-00027
• Device Sequence Number: 21327002
• Product Code: FMI
• UDI-Device Identifier: 00382903059164
• UDI-Public: (01)00382903059164
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: Other
• Device Catalogue Number: 305916
• Device Lot Number: UNKNOWN
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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