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

Catalog Number	305902
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
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 the bd needle sftygld 23x1 rb had leakage.The following information was provided by the initial reporter: material #305902, batch #5280959.Verbatim: rcc received a complaint via email.Email(s) attached.Patient was here for b12 injection, dose was drawn up with blunt tip needle and then im needle placed for administration.Skin was pierced in usually fashion for injection, when medication was to be administered, it was noted that the medication was leaking out of needle hub.Needle was removed, safety shield deployed and reevaluated.Medication was leaking from hub where needle and hub meet.Pharmacy notified and replacement dose was issued.Needle used bd safetyglide ref 305902 lot 5280959, exp 9/30/30.
Additional Manufacturer Narrative
Additional information: (h) attached medwatch.Investigation results: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.
Event or Problem Description
No additional information.

• 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: 24089954
• Report Number: 1213809-2026-00008
• Device Sequence Number: 10469564
• Product Code: FMI
• UDI-Device Identifier: 00382903059027
• UDI-Public: (01)00382903059027(11)251007(17)300930(10)5280959
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 305902
• Device Lot Number: 5280959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female