MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16GX1-1/2IN RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305198
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	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported foreign matter.Event description: material # 305198 batch # 4159531, 4247109 reported issue: it is not embedded in the plastic, and it does scrape off.Injuries or adverse event: no item: 305198quantity affected: 2bx additional information i sent the attached email to medline after learning that additional lots were impacted.The two additional lots were also found to have the same dark material.Can you please include these additional lots to the report?.
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 for device evaluation.A customer report was received indicating the presence of foreign matter on the plastic component.To support the investigation, six sealed blister-packaged samples were submitted for evaluation by the quality team¿three from lot 4159531 and three from lot 4277109.A visual inspection was conducted on all samples.No defects, imperfections, or foreign matter were observed.A device history record (dhr) review was performed for material number 305198, specifically for lots 4159531 and 4277109.The review did not identify any quality issues during the manufacturing process that could be associated with the reported condition.No related quality notifications were found, and all production processes and final inspections were completed in accordance with specification requirements.Based on the analysis of the returned samples, the reported condition could not be confirmed.

• Brand Name: NEEDLE 16GX1-1/2IN 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: 22809097
• Report Number: 1911916-2025-00579
• Device Sequence Number: 7797930
• Product Code: FMI
• UDI-Device Identifier: 00382903051984
• UDI-Public: (01)00382903051984(17)291031(10)4247109
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 305198
• Device Lot Number: 4247109
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown