MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SAFETYGLIDE LUER-LOK; SYRINGE, ANTISTICK

Catalog Number	305905
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: a complaint history check was not performed as the lot number is unknown for this complaint.A device history record review was not performed as the lot number is unknown for this complaint.A review of the applicable risk document indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.The root cause was not concluded due to unavailability of batch information.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It is reported safety mechanism failure.Description: our staff encountered a needle stick injury after medication administration with one of our patients.Apparently, with the reports received and investigation, the needle failed to locked and thus it retract backwards which resulted to injury.

• Brand Name: SAFETYGLIDE LUER-LOK
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24559076
• Report Number: 1911916-2026-00109
• Device Sequence Number: 12994974
• Product Code: MEG
• UDI-Device Identifier: 00382903059058
• UDI-Public: (01)00382903059058
• 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): 03/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305905
• Device Lot Number: UNKNOWN
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown