MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE; SYRINGE, ANTISTICK

Catalog Number	305950
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material #305950.Lot #4106019.It was reported that the bd safetyglide safety mechanism was difficult to activate.The following information was provided by the initial reporter: verbatim: having an issue with the allergy needles reff # 305950, lot# 4106019 safety not engaging, and issue of sharpness of needle (not puncturing skin).
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: one video was received and analyzed by our quality team with the customer's complaints of safety not engaging and dull needle.The complaints were verified with the video alone but the root cause is unknown without the affected sample for investigation.The manufacturing plant has been made aware of this issue.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Video received.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 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: 21619973
• Report Number: 1920898-2025-00006
• Device Sequence Number: 18254317
• Product Code: MEG
• UDI-Device Identifier: 00382903059508
• UDI-Public: (01)00382903059508(11)240709(17)290430(10)4106019
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 305950
• Device Lot Number: 4106019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown