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	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description/event details: the customer complained that foreign body was found on the needle.
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.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there was a foreign body found on the needle.To aid in the investigation, three samples and three photos were received for evaluation by our quality team.A visual inspection was performed.Two samples have a dark colored speck of embedded degraded resin at the bottom part of the needle hub.The third sample has droplets of lubricant on the needle.The three photos provided show the samples received.No other defects or imperfections were observed.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.The droplet condition on the needle occurs if there is a failure in the valve controlling the lubricant.A device history record review was completed for provided material number 305198, lot 2175419.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported condition.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation with the returned sample analysis the symptom reported by the customer is 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: 21827382
• Report Number: 1911916-2025-00277
• Device Sequence Number: 9244594
• Product Code: FMI
• UDI-Device Identifier: 30382903051985
• UDI-Public: (01)30382903051985(11)220624(17)270930(10)2175419
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 2175419
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown