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

Catalog Number	305901
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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 needle pulled out of hub.Complaint via phone.Case description: the bd safetyglide¿ needle 25 g x 5/8 in is presenting issues with a couple of samples, the customer informed that the needle detached from the hub and the needle got stuck in the hub.He mentioned that this happened three times.Product: bdsafetyglide¿ needle 25 g x 5/8 in.Ref#: 305901, lot#: 5080421, customer response on 25-mar-2026.1.Can you please provide an exact date of event in format mm-dd-yyyy? around 09-03-2026.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.None reported by the patient.3.Could you please confirm if any samples are available for return so we can investigate further? no samples available.Customer response on (b)(6) 2026.Did the needle detach from the hub and remain in patient? yes.The needle detached from the hub.(the needle was stuck in the vial- not the patient).If yes, was needle removed fully intact with no further follow up? the needle was removed intact (it go stuck in the vial-rubber stopper while attempting to withdraw the medication from the vial).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation summary: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.

• 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: 24796290
• Report Number: 1213809-2026-00179
• Device Sequence Number: 18514669
• Product Code: FMI
• UDI-Device Identifier: 00382903059010
• UDI-Public: (01)00382903059010(11)250321(17)300228(10)5080421
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: Other
• Device Catalogue Number: 305901
• Device Lot Number: 5080421
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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