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

Catalog Number	305902
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
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 safety mechanism was difficult to activate.The following information was provided by the initial reporter: material # 305902.Batch #5023870.It was reported by the customer that the safety mechanism on the needle would not engage after injection.Verbatim: rcc received a complaint via email.We received the below feedback concerning an adverse event involving item 305762.Lot number is 5023870.I am not seeing any record of this lot presenting any issues within our space prior.Please advise on next steps and if this is the first you're hearing of this when it comes to this lot number.¿injected immunization in child with 23gx1" needle lot 502387 exp: 12/31/2029.Examined needle and it was on immunization correctly after needle was removed from right ventrolateralis, attempted to engage safety on needle with thumb.The safety would not engage and pushed off of immunization falling to floor.Attempted to engage safety of needle while on the floor but safety would not engage.Had to dispose of immediately in sharps without safety engaged.¿ customer responded on (b)(6).1.Can you please provide an exact date of event in this format mm-dd-yyyy? 05/01/2025.2.Provided lot # 5023870 number is not matching with provided material #305762.Please check and provide the correct lot number & material number.This is a 23 g 1" bd safetyglide injection needle lot# 5023870 exp 12/31/2029, ref (unsure what this means but i will include it) is (b)(4).3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.There was no harm to the patient or employee.Additional information provided: 1.Can you please provide an exact date of event in this format mm-dd-yyyy? i'm sorry i was multitasking.The event date was 4/29/2025.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number 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.

• 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: 22055730
• Report Number: 1213809-2025-00340
• Device Sequence Number: 4109745
• Product Code: FMI
• UDI-Device Identifier: 00382903057627
• UDI-Public: (01)00382903057627(10)5023870
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 305902
• Device Lot Number: 5023870
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown