MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305902
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle sftygld 23x1 rb needle pulled out of hub.Complaint via email.Email(s) attached.Per (b)(6) during a vaccine injection the needle separated from the hub and was left in the patient's leg.No struggle/issue with shot.It just had separated and left needle in the leg.Hsi control number: 129056 hsi description: safetyglide needle hsi item number: us_9875902 hsi manufacturer part number: 305902 hsi lot or serial number: (b)(6).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up it was reported the needle separated from the hub during the injection.A device history record review was completed for provided material number 305902, lot 5280958.The review revealed all visual inspections were performed per requirements with no quality notifications related to the condition reported.The lot was inspected and accepted based on our inspection control plan and approved for shipment.Additional device histories were reviewed for each lot of needles used in the manufacturing of this final lot.There was no documentation for this type of defect during the entire production run of these lots.Due to the unavailability of a sample for return, a comprehensive sample investigation could not be conducted.Consequently, the exact cause of this incident remains undetermined.Should you encounter any further issues with our product, we would appreciate the opportunity to perform a detailed analysis.At this time, no further action is deemed necessary.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24831054
• Report Number: 1213809-2026-00186
• Device Sequence Number: 13066892
• Product Code: FMI
• UDI-Device Identifier: 00382903059027
• UDI-Public: (01)00382903059027(11)251007(17)300930(10)5280958
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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): 05/07/2026

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: Other
• Device Catalogue Number: 305902
• Device Lot Number: 5280958
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2025
• 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 Sex: Unknown