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

Catalog Number	305918
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle sftygld 18x1-1/2 rb had leakage.The following information was provided by the initial reporter: material#: 305918, batch#: 5008609.Rcc received a complaint via email.Incident or problem information, mdip reference number (id): (b)(4), date of incident: on (b)(6) 2025, type of incident/problem: failure (i.E.While preparing for, in use, after use), level of harm: no apparent harm - reached the patient/person -- inconvenient, ahs optional report to cmdsnet (health canada): incident details: using sefetyglide needle 18g x 1/2" to draw up magnesium - magnesium dripping out of needle where it is connected to pink base.Impact of incident: spilled magnesium everywhere, risk if drawing up cytotoxic medications who was affected? healthcare professional.Device information: device name/description: needle hypodermic safety glide 18 gauge x 1.5 inch, manufacturer: becton dickinson canada inc, manufacturer code/model: 305918, serial or lot number: (b)(6), expiry date: 2029-12-31, supplier: (b)(6), supplier/catalogue number: 308-305918, is the device retained? yes.Investigation request: expected type of investigation: actual device tested; lot review.
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
(b)(4) - supplemental mdr - leakage.One sample was provided to the quality team for investigation, received in an opened blister package and missing a plastic shield.Visual inspection revealed that the epoxy securing the needle to the hub did not fully cover the circumference of the needle.The sample was assembled to a syringe with saline solution, and leakage was observed at the needle hub¿needle joint.The reported symptom was confirmed through investigation and sample analysis.A probable root cause could be a jam at the cannulator during assembly, which may have gone undetected in subsequent processes.Verification of the cannulator was performed.The settings were correct, and flow of products was good.Furthermore, a device history record review was completed for provided lot number 5008609.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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: 22324582
• Report Number: 1213809-2025-00434
• Device Sequence Number: 9023293
• Product Code: FMI
• UDI-Device Identifier: 30382903059189
• UDI-Public: (01)30382903059189(11)250108(17)291231(10)5008609
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 305918
• Device Lot Number: 5008609
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown