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

Catalog Number	305932
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/11/2025
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 syringe 0.5ml 29ga 1/2in bls 400 sg safety mechanism was difficult to activate.The following information was provided by the initial reporter: material #305932; lot #4254095.Verbatim: rcc received a complaint via email.After i administered subcutaneous insulin and removed the needle from the patient's skin, i went to engage the safety device for the needle.The white safety device for the insulin needle slipped, which caused my right hand to move forward, further causing the needle to puncture the inner part of my left index finger.I tried to activate the safety device, but the device slipped, which the safety device was faulty.Needlestick occurred.
Additional Manufacturer Narrative
Investigation summary: no photo or sample was received for the customer's complaint of safety mechanism issues.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.The manufacturer has been notified of this occurrence.

• Brand Name: 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: 22458360
• Report Number: 2243072-2025-00837
• Device Sequence Number: 8155727
• Product Code: MEG
• UDI-Device Identifier: 00382903059324
• UDI-Public: (01)00382903059324(17)290930(10)4254095
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: 305932
• Device Lot Number: 4254095
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown