MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1-1/2 SB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305199
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description: epoxy on needle.Event details: several needles with a large glob of dried white material where the metal part of the needle attaches to the pink hub.Material # 305199, batch # 1027259.
Additional Manufacturer Narrative
H11 -a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(6) follow up for device evaluation.A report was received indicating the presence of a large glob of dried white material at the junction where the metal needle connects to the pink hub.To support the investigation, one unpackaged sample and a corresponding photograph were submitted for evaluation by the quality team.A visual inspection of the sample was conducted.The needle hub exhibited an epoxy overflow.The photograph confirmed the condition observed in the returned sample.No additional defects or irregularities were identified.This issue is known to occur during the assembly process, specifically when a jam occurs at the cannulator.A device history record (dhr) review was completed for material number 305199, lot 1027259.The review did not identify any quality issues during production that could have contributed to the reported condition.No related quality notifications were found.All manufacturing processes and final inspections were performed in accordance with specification requirements.Cannulator verification confirmed that the settings were accurate, and product flow was consistent.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer-reported condition has been confirmed.

• Brand Name: NEEDLE 18X1-1/2 SB
• 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: 22531141
• Report Number: 1911916-2025-00527
• Device Sequence Number: 8017925
• Product Code: FMI
• UDI-Device Identifier: 00382903051991
• UDI-Public: (01)00382903051991(17)260331(10)1027259
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 305199
• Device Lot Number: 1027259
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown