MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 23GA 1-1/2IN BNS TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	304142
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported by customer that the debris found inside the needle casing.Verbatim: debris found inside the needle casing supplier product #: 304142 lot #: 4331011 customer response on 03-jun-2025.Can you please provide an exact date of event? 5/28/2025.
Additional Manufacturer Narrative
(b)(4), follow up for device evaluation: debris was reported inside the needle casing.To support the investigation, one unpackaged sample and one photograph were submitted for evaluation by the quality team.A visual inspection was conducted, revealing an epoxy drip on the needle hub.The photograph confirmed the condition observed in the received sample.No additional defects or irregularities were identified.This issue can occur during the assembly process if a jam occurs at the cannulator.A device history record (dhr) review was completed for material number 304142, lot 4331011.The review found no quality issues during the production of this lot that could have contributed to the reported condition.No related quality notifications were identified.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 similar incidents 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 23GA 1-1/2IN BNS TW
• 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: 22162616
• Report Number: 1911916-2025-00398
• Device Sequence Number: 18313615
• Product Code: FMI
• UDI-Device Identifier: 00382903041428
• UDI-Public: (01)00382903041428(11)241126(17)291130(10)4331011
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/18/2025

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: 304142
• Device Lot Number: 4331011
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown