MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 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	12/18/2025
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 needle pulled out of the hub.The following information was provided by the initial reporter: material #:305901 batch#:5301004 verbatim: subq needle malfunction upon administration.Rn drew up atropine as ordered with red blunt fill needle.Switched needle to subq needle per standard process for injection administration.Drug given in entirety and rn went to initiate safety mechanism on needle before disposal.Needle detached from device at syringe end of needle and remained in patient¿s abdomen sticking out.Rn then had to carefully pull bare needle from patient¿s abdomen for disposal as it was no longer attached to the rest of the safety device.Verified again that needle was not expired and still within date for appropriate use.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4).- supplemental mdr - needle pulled out of hub one photo was provided showing a packaging blister top web with a syringe and needle assembly positioned beside it.The syringe is shown without the needle attached, and the needle is placed separately next to the assembly.Based on the investigation and review of the photo evidence, the reported condition is confirmed.A device history record review was completed for material number 305901, lot 5301004.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 is in compliance with applicable product specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly, and our business team regularly reviews the collected data to identify any emerging trends.

• 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: 23984927
• Report Number: 1213809-2025-00809
• Device Sequence Number: 14597030
• Product Code: FMI
• UDI-Device Identifier: 00382903059010
• UDI-Public: (01)00382903059010(11)251028(17)300930(10)5301004
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 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: 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: 12/19/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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