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

Catalog Number	305903
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 1ml s/t w/ndl sftygld 25x5/8 rb needle pulled out of the hub.The following information was provided by the initial reporter: material#: 305903, batch#: 5122689, 305903, 5122689.One of our icu nurses was administering heparin using a bd safety glide.Once she gave the heparin and was attempting to engage the safety, the needle portion flew off of the syringe and then punctured her arm.
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) - supplemental mdr - needle pulled out of hub.One photo of a 1 ml luer lok syringe with a 25 x 5/8" safetyglide needle (part number 305903, batch 5122689) was received and reviewed.The image shows a loose syringe with the safetyglide needle unattached, placed next to the top web slip containing all required product information.The reported defect could not be confirmed from the photo provided, and the condition observed is acceptable per product specifications.A device history record review was completed for material number 305903, lot 5122689.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and complies with applicable product specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly, and our business team regularly reviews the collected data to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: 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: 24145440
• Report Number: 1213809-2026-00021
• Device Sequence Number: 9210398
• Product Code: FMI
• UDI-Device Identifier: 00382903059034
• UDI-Public: (01)00382903059034(11)250502(17)300430(10)5122689
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 305903
• Device Lot Number: 5122689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown