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

Catalog Number	305901
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
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 the bd needle sftygld 25x5/8 rb safety mechanism broke.The following information was provided by the initial reporter: material#: 305901 batch#: 5301004.The nurse administered the medication and when she attempted to engage the safety mechanism, she noted that the plastic on the safety guard was broken and the needle was no longer attached to the syringe.The 25-gauge sq needle was in the injection site (abdomen) of the patient.A second needle was defective; the needle didn't release but when engaging safety it bent in half.305901, 5301004.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - safety mechanism broke (safetyglide).One photo was provided showing a needle assembly attached to a syringe without a plastic shield and with the safety mechanism already activated.The needle appears bent near the midpoint of its length, and no additional information can be determined from the image alone.Based on the investigation and review of the photo, the reported symptom is confirmed; however, without an actual physical sample, a probable root cause cannot be determined.A device history record review was completed for material number 305901, lot 5301004, and all in process and final visual inspections were performed as required.No quality notifications related to the reported condition were identified.The lot met all acceptance criteria per the inspection control plan, was approved for shipment, and complies with applicable product specifications.We appreciate you bringing this observation to our attention.Complaints associated with this device and condition will continue to be tracked and trended, with information captured in monthly trend reports and regularly reviewed by our business team 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: 24115295
• Report Number: 1213809-2026-00014
• Device Sequence Number: 18475259
• Product Code: FMI
• UDI-Device Identifier: 00382903059010
• UDI-Public: (01)00382903059010(10)5301004
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: 5301004
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown