MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC BD SAFETYGLIDE; SYRINGE, ANTISTICK

Catalog Number	305935
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 0.3ml 29ga 1/2in bls 400 sg safety mechanism broke.The following information was provided by the initial reporter: material # 305935, batch # 4254075a.Verbatim: rcc received a complaint via email.Xxxxx, you have not responded to several of many emails that i have sent to you.So, i am copying xxxx for help in routing this email to the correct person in case you are no longer with bd.Bd product 305935, lot # 425075a, had malfunctioned when trying to use.From the nurse "when taking the protective cap off of a 3/10ml syringe the safety cap came off with the top cap.Leaving the needle free to stick anyone." i have the product on my desk if you need me to send it into bd.Additional information provided: can you please provide an exact date of event? 08/nov/2025.Batch number 425075a was not found in our system, kindly verify the same.The lot number is 4254075a.What was the impact to the patient? none.If possible, could you please provide picture samples for investigation? please see the attached.
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
Photos.
Additional Manufacturer Narrative
Investigation summary: 2 photos were received and analyzed by our quality team with the customer's complaint of safety mechanism failure.The photos alone are enough to verify the complaint as the safety mechanism is completely detached from set.The root cause of this issue is unknown without the physical sample for investigation.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23720700
• Report Number: 2243072-2025-01451
• Device Sequence Number: 10209001
• Product Code: MEG
• UDI-Device Identifier: 00382903059355
• UDI-Public: (01)00382903059355(10)4254075A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• 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): 01/22/2026

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: 305935
• Device Lot Number: 4254075A
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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