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

Catalog Number	305901
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd 305901 needle sftygld 25x5/8 rb needle pulled out of hub.Verbatim: it was the bd safetyglide needle ref# 305901 lot# 5080421.The needle was inserted into a vial.When the needle was being removed from the vial, the needle separated from the hub.No patient was harmed.The needle was put in a sharps container, but we have retained the hub and packaging for inspection if needed.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.E.1.Address was not located, and il was used.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation the reported issue was a separation of the needle from the hub.One sample in an opened blister package was received and evaluated by the quality team.Visual inspection found the needle assembly lacked the needle.The top of the needle hub had epoxy covering approximately 340 degrees of the orifice.No other defects or imperfections were observed.This condition may occur in the event of a cannulator jam.A device history record review was completed for material number 305901, lot 5080421.All in process and final visual inspections were performed per requirements, with no quality notifications related to the reported condition.The lot met acceptance criteria per the inspection control plan and was released to distribution.Additional dhrs for each batch of needles used in manufacturing this final lot were also reviewed, there was no documentation of this defect during the production runs.The cannulator was verified, with settings within specification and acceptable product flow.To date, no similar events have been reported for this lot.Based on the investigation, including analysis of the returned sample, the customer reported condition is confirmed.

• 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: 23908944
• Report Number: 1213809-2025-00796
• Device Sequence Number: 15726586
• Product Code: FMI
• UDI-Device Identifier: 00382903059010
• UDI-Public: (01)00382903059010(11)250321(17)300228(10)5080421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 305901
• Device Lot Number: 5080421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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