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	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle sftygld 25x5/8 rb 305901 needle pulled out of hub.After administering a flu vaccine today, (b)(6) 2025, i proceeded to activate the safety on the needle.When touching the bottom of the safety feature, the needle came off of it's "hub".The needle was a 25 gauge 5/8".No injury occurred; however, i am reporting this incident to the manufacturer as was instructed in the recall of the 1" needles.I am also notifying my practice and regional managers.Lot# 5214203 exp 7/31/2025.
Additional Manufacturer Narrative
(b)(4) follow up a report was received indicating the needle detached from the hub.Because a physical sample was not returned, a comprehensive evaluation could not be performed.One photograph was provided for assessment by the quality team.The image shows a syringe with the safety mechanism activated and the needle assembly partially disengaged from the hub.No other defects or imperfections were observed.A device history record review was completed for material number 305901, lot 5214203.The review confirmed that all required visual inspections were performed per specification, with no quality notifications related to the reported condition.The lot was inspected and accepted in accordance with the inspection control plan and subsequently approved for shipment.Device history records for each lot of needles used in manufacturing this final batch were also reviewed, no documentation of this defect type was identified during the production runs of those lots.To date, no similar events have been reported for this lot.Based on the investigation, including the photographic assessment, the customer reported symptom is confirmed.In the absence of the physical sample, a probable root cause could not be determined.

• 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: 23921722
• Report Number: 1213809-2025-00797
• Device Sequence Number: 9012714
• Product Code: FMI
• UDI-Device Identifier: 00382903059010
• UDI-Public: (01)00382903059010(11)250802(17)300731(10)5214203
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/27/2026

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: 5214203
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2025
• 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