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	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and il was used.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 syringe 0.3ml 29ga 1/2in bls 400 sg safety mechanism was difficult to activate.The following information was provided by the initial reporter: material: 305935, batch#: 4163120.Rcc received a complaint via community.While preparing to give insulin it was noted that syringe was defective.The safety mechanism would get stuck in the cap or as you would go to remove the cap to draw up it would come flying off the needle.I checked the lot number and realized it was lot#: 4163120n1 and we checked a few from the lot and realized there was a few that were defective and some were fine.
Additional Manufacturer Narrative
4 photos were received and analyzed by our quality team with the customer's complaint of safety mechanism failure.The photos verified the complaint as the safety shield was completely separated from the syringe barrel assembly.The root cause of this issue is operator error at time of safety mechanism to syringe assembly due to improper setting of safety mechanism to syringe.Corrective action is not possible due to the assembly line being shut down during plant closure.Multiple attempts were made to acquire the device production history but due to plant closure the records could not be obtained.If there were quality alerts or abnormalities for this lot# these would be evident and reported.In this case quality defects in this lot are unlikely.
Event or Problem Description
Photos.

• 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): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23723382
• Report Number: 2243072-2025-01452
• Device Sequence Number: 16125152
• Product Code: MEG
• UDI-Device Identifier: 00382903059355
• UDI-Public: (01)00382903059355(17)290630(10)4163120
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/12/2026

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: 4163120
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown