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

Catalog Number	305916
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle sftygld 25x1 rb had a syringe needle connectivity issue.Verbatim: complaint via email.Email(s) attached.Medical device problem report to vendorrequest for lot/complaints review.Mdip # (b)(4).Device available for investigation: no.Please see the below device problem report.No serious harm was reported.Unfortunately, the device is not available for investigation.A production lot review (when lot number provided) and a summary report of complaints, problems and incidents (including level of harm) associated with this device is requested, to be provided within ninety (90) days.Thank you for participating in the alberta medical device safety incident or problem reporting and investigation process.Please contact me if you have any questions.Ahs mdip report: 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: no apparent harm - reached the patient/person -- inconvenient.Optional report to cmdsnet (health canada): incident details: client was in for routine 12 moth immunizations.All vaccines were prepared per protocol.Upon administration of vaccine, nurse went to inject vaccine into left arm, but vaccine disconnected from needle port and sprayed forcefully back into the nurse face and eyes.All of vaccine was sprayed back into nurse's face, none was administered.Another poke was done in the left leg of the meningococcal vaccine full dose was given.The device was faulty.Upon administration it disconnected itself while still in the client¿s arm and sprayed back into my face.I didn¿t hit bone nor did i apply enough pressure for it to disconnect so aggressively and spray backwards towards me.Device name/description: needle hypodermic safety 25ga x 1 in.Manufacturer: becton dickinson canada inc.Manufacturer code/model: 305916.Serial or lot number: 2287687.Supplier: canada corporation.Supplier catalogue number: (b)(4).Was the device retained? no.Investigation request.Expected type of investigation: lot review.Clinical contact information.Additional info: i wasn't trying to pull the needle out when it broke away from the safety device, i was trying to administer the vaccine into the arm when it sprayed back into my face.It seemed as if there was something blocking the section of the needle that passes the fluid and forcefully sprayed back.My main issue was that i didn't hit bone or push hard enough during the administration for the vaccine, fluid and equipment to have responded that way.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Additional information: d.4.Udi investigation summary: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A physical sample is required for a more thorough evaluation and potential root cause determination.We will continue monitoring the complaint trend for the product and symptom.Batch 2287687 is considered in compliance with our product specification requirements.The complaint was not confirmed, and no capa evaluation was required.This complaint type will continue to be trended within the post-market surveillance process, and any determined escalation will be managed there.
Event or Problem Description
No additional information.

• Brand Name: BD 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: 24877037
• Report Number: 1213809-2026-00199
• Device Sequence Number: 18474548
• Product Code: FMI
• UDI-Device Identifier: 00382903059164
• UDI-Public: (01)00382903059164(11)221014(17)270930(10)2287687
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 2287687
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2022
• 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