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	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description: it is reported foreign matter.Event details: it was reported by customer that "it is not embedded in the plastic, and it does scrape off." injuries or adverse event: no.Item: 305198.
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.A report was received indicating the presence of foreign matter on the plastic component.To support the investigation, ten sealed blister-packaged samples and one photograph were submitted for evaluation by the quality team.The samples included five units from lot 4332683 and five units from lot 5056705.A visual inspection was conducted using 10x magnification.No defects, imperfections, or foreign matter were observed on any of the samples.The submitted photograph depicts a needle hub outside of its blister packaging, with a dark-colored speck visible.Based on the image, the speck appears consistent with burnt resin; however, no additional information could be determined from the photograph alone.A device history record (dhr) review was completed for material number 305198, covering lots 4332683 and 5056705.The review did not identify any quality issues during production that could be linked to the reported condition.No related quality notifications were found, and all manufacturing processes and final inspections were performed in accordance with specification requirements.Based on the investigation, the customer-reported symptom is confirmed through photographic evidence.Due to the absence of the actual physical sample for analysis, a probable root cause could not be determined.

• 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: 22698197
• Report Number: 1911916-2025-00555
• Device Sequence Number: 15712678
• Product Code: FMI
• UDI-Device Identifier: 00382903051984
• UDI-Public: (01)00382903051984(17)300131(10)5056705
• 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): 08/15/2025

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: 5056705
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown