MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305128
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/07/2025
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.
Event or Problem Description
Verbatim/event details: material # 305128 lot # 4159370 i am writing to report a recent incident involving a 30-gauge needle that broke off at the hub during local infiltration of a patient's breast in preparation for aspiration of a hematoma.The needle detached at the hub while numbing fatty breast tissue, raising concerns about product integrity.Additional information the pt had to be taken to the operating room for surgery the next day to remove the retained needle.The harm would be a surgical procedure to remove.
Additional Manufacturer Narrative
(b)(6) follow up for device evaluation a report was received indicating that the needle had separated from the hub.To support the investigation, one sample in an opened blister package and three accompanying photographs were submitted for evaluation by the quality team.A visual inspection was conducted using magnifications of 10x and 30x.The inspection revealed that the lower portion of the needle remained secured within the hub by epoxy, while the needle itself was fractured above the epoxy bond.The upper segment of the needle exhibited signs of bending or crimping.The submitted photographs depicted the needle assembly with its plastic shield, a shelf box, and the top web of the blister packaging.A review of the device history record (dhr) was completed for material number 305128, lot 4159370.The review found no quality issues during the manufacturing process that could have contributed to the reported condition.No related quality notifications were identified.All manufacturing processes and final inspections were performed in accordance with specification requirements.The sample was shown to production associates; none of whom reported having observed similar damage.Additionally, no other similar incidents have been reported for this lot to date.Based on the analysis of the returned sample, the reported issue was confirmed.However, the investigation was unable to determine a probable root cause.

• Brand Name: NEEDLE 30X1 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: 22069879
• Report Number: 1911916-2025-00367
• Device Sequence Number: 18242183
• Product Code: FMI
• UDI-Device Identifier: 30382903051282
• UDI-Public: (01)30382903051282(11)240607(17)290731(10)4159370
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305128
• Device Lot Number: 4159370
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown