MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC BD SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB; 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	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and (b)(6) 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 sftygld 1ml w/ndl 27x1/2 rb had leakage.The following information was provided by the initial reporter: material # 305945.Batch # 4228049.Verbatim: rcc received a complaint via email.Situation: we had an event today where a nurse was using this needle, she did two good pokes, and the needle would not pierce the skin (this is the actual wrapper for that needle).She said that she also had one of these needles that leaked when she was injecting (i don¿t have the wrapper for that one).Let me know if you have any questions.Background: event date: 04/03/2025 ih #: (b)(4) syringe tb 1ml 27gax.5 safetyglide.Mfg #: (b)(4) sample available: no.Lot #: 4228049e1 assessment: credit requested: no.Was there injury? no.
Additional Manufacturer Narrative
Imdrf codes must be updated.
Event or Problem Description
Imdrf codes must be updated.

• Brand Name: BD SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB
• 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: 21877226
• Report Number: 2243072-2025-00553
• Device Sequence Number: 7899319
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: (01)00382903059454(11)241024(17)290831(10)4228049
• 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): 08/12/2025

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: 305945
• Device Lot Number: 4228049
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown