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

Catalog Number	305198
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Description: foreign matter.Verbatim: material no: 305198 batch no: 4305226 one of our pharmacy technicians was getting ready to use this needle to prepare an iv product and noticed a dark spot, either a contaminant or a plastic defect, inside the hub of the needle.It was not used for a patient and so there was no harm.He set it aside without using it and contacted me.
Additional Manufacturer Narrative
(b)(6) follow up for device evaluation.A customer reported the presence of either a contaminant or a plastic defect within the hub of a needle.To support the investigation, one sample in an opened packaging blister was received and evaluated by the quality team.A visual inspection revealed dark-colored specks embedded in the needle hub, identified as degraded resin.No additional defects or irregularities were observed.The presence of embedded degraded resin is typically associated with the startup phase or intermittent conditions during the injection molding process.During these periods, degraded resin may dislodge and become incorporated into molded components.A device history record (dhr) review was conducted for material number 305198, lot 4305226.The review did not identify any quality issues during production that could have contributed to the reported condition.No related quality notifications were found, and all manufacturing processes and final inspections were performed in accordance with specification requirements.The sample will be shared with production associates to raise awareness.To date, no other similar complaints 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 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: 22449479
• Report Number: 1911916-2025-00512
• Device Sequence Number: 15542899
• Product Code: FMI
• UDI-Device Identifier: 00382903051984
• UDI-Public: (01)00382903051984(17)300131(10)4305226
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 4305226
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown