MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2025
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#: 305127.Batch#: 4081101.Verbatim: rcc received a complaint via email.Breaks during operation.Additional info: thank you for your reply.Unfortunately, i do not have any additional information available to me to provide regarding these return requests.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported the product breaks during operation.To aid in the investigation, two hundred twenty-five samples in sealed packaging blisters were received for evaluation by our quality team.Eighty samples were randomly selected for investigation.A visual inspection was performed with 30x magnification.No defects, imperfections or damages were observed.A device history record review was completed for provided material number 305127, lot 4081101.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 with the returned sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
No additional information received.

• Brand Name: NEEDLE 25X1-1/2 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: 21433536
• Report Number: 1911916-2025-00135
• Device Sequence Number: 4528581
• Product Code: FMI
• UDI-Device Identifier: 30382903051275
• UDI-Public: (01)30382903051275(11)240321(17)290630(10)4081101
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/05/2025

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: 305127
• Device Lot Number: 4081101
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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