MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305125
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material: 305125 batch#: 4060114 verbatim: the needle is acting blocked and won¿t inject.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation: it was reported the needle is acting blocked and won¿t inject.To aid in the investigation, eight hundred forty-four samples in sealed packaging blisters was received for evaluation by our quality team.Eighty samples were randomly selected for investigation, a visual inspection was performed, and no defects or imperfections were observed.Each sample was then assembled to a syringe with saline solution.All the samples expelled the solution with a normal flow.A device history record review was completed for provided material number 305125, lot 4060114.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
Additional information received.No adverse event.

• Brand Name: NEEDLE 25X1 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 21103371
• Report Number: 1911916-2024-00984
• Device Sequence Number: 9155001
• Product Code: FMI
• UDI-Device Identifier: 30382903051251
• UDI-Public: (01)30382903051251(11)240229(17)290430(10)4060114
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 01/25/2025

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: 305125
• Device Lot Number: 4060114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 01/25/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown