MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 23X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305902
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - leakage as neither a lot number nor a sample was available for this incident, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.
Event or Problem Description
Materials: 305902, batch#: unknown.It was reported that the bd needle sftygld 23x1 rb had leakage.The following information was provided by the initial reporter: it was reported by the customer that; the medication leaked out of the needle - through the middle of the needle.Rcc received a complaint via email.Writer prepared an im injection for a patient.Needle was on syringe tight and needle was primed with medication (ceftriaxone).Once patient was injected with needle, writer attempted to push medication.The medication leaked out of the needle - through the middle of the needle.Patient had to get a second im injection due to the defective needle not delivering previous dose.Item: 305902.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD NEEDLE SFTYGLD 23X1 RB
• 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: 21627497
• Report Number: 1213809-2025-00205
• Device Sequence Number: 12849684
• Product Code: FMI
• UDI-Device Identifier: 30382903059028
• UDI-Public: (01)30382903059028
• Combination Product (Y/N): Y
• 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): 03/18/2025

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: 305902
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown