MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305106
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle 30x1/2 rb had leakage.The following information was provided by the initial reporter.Material: 305106, batch#: 4081033.Verbatim: rcc received a complaint via email.Email(s) attached.Complaint number: (b)(4).Complaint description: on 30jul2025 xx was informed of an event with eylea 8mg vial kit which was categorized with the defect component issue ¿ defective syringe.On 28jul2025, the office staff reported the following: ¿when the doctor attempted to remove the injection needle cap, it automatically started "shooting out (the medication)" without pressing the plunger.¿ lot: 8463800035 injection needle, catalog: 305106, lot: 4081033.Investigational request /return component status please perform an evaluation of the process and sample to determine any potential contributing factors to the needle blockage.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported that upon removing the injection needle cap, the medication began dispensing automatically.Because a physical sample was not returned, a comprehensive evaluation could not be performed.To support the investigation, two photographs were provided for review by the quality team.The first image shows a needle assembled to a syringe, focusing on the connection between the needle hub and the syringe luer lock.The second image depicts a needle assembly with the plastic shield in place.No additional information could be obtained from these photographs.A review of the device history record was conducted for material number 305106, lot 4081033.The review confirmed that no quality issues were detected during the production of this lot that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections were performed in compliance with specification requirements.Based on the investigation and the photographic analysis, the reported symptom could not be confirmed.Without the physical sample for evaluation, it was not possible to determine a probable root cause.

• Brand Name: BD PRECISIONGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23596423
• Report Number: 1911916-2025-00750
• Device Sequence Number: 10380123
• Product Code: FMI
• UDI-Device Identifier: 00382903051069
• UDI-Public: (01)00382903051069(17)290531(10)4081033
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 11/20/2025

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: 305106
• Device Lot Number: 4081033
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown