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

Catalog Number	305945
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
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 bd syringe sftygld 1ml w/ndl 27x1/2 rb was noted to have leakage.Rcc received a complaint via email.When applying a tb test with the tuberculin syringe, the solution was leaking from the hub of the needle and not the lumen.Customer response on (b)(6) 2026.I suppose i cannot confirm the exact lot# if that is not an active number.The two i have in clinic are: 4310099d1 exp: 11/20/2029.3227561j1 exp: 08/31/2028.Which appears to be a combination of both lots.Maybe the expiration can help identify which one based on what i sent you earlier? i am not familiar with the material number, is it this? ref: 305945.The only negative outcome is that i had to poke the patient 2x but she was understanding with it.

• 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: 24474690
• Report Number: 2243072-2026-00134
• Device Sequence Number: 10308603
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: (01)00382903059454(11)250115(17)291130(10)4310099
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 305945
• Device Lot Number: 4310099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Race: White