MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305196
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, 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.
Event or Problem Description
It is reported foreign matter event description material: 305196 lot: 5092808 no one was injured.Hurt.Affected.I opened an unopened hypodermic needle, and it has white gunk on it.The white stuff is normally securing the base of the needle but this one has like melted or something - splattered.Unsafe for use on a patient.
Additional Manufacturer Narrative
(b)(4) follow up a complaint was received regarding a hypodermic needle exhibiting a white residue.To support the investigation, three photographs were submitted and reviewed by the quality team.The images depict a needle assembly removed from its blister packaging, showing an epoxy drip on the needle hub.No additional defects or irregularities were observed.This condition is consistent with an issue that can occur during the assembly process due to misfeeding of the cannulator.A device history record (dhr) review was conducted for material number 305196, lot 5092808.The review did not identify any quality issues during the production of this lot that could have contributed to the reported condition.No related quality notifications were found.All manufacturing processes and final inspections were performed in accordance with specification requirements.Cannulator verification confirmed that the equipment settings were accurate, and product flow was within acceptable parameters.To date, no similar complaints have been reported for this lot.Based on the investigation and photographic evidence, the customer-reported condition has been confirmed.

• Brand Name: NEEDLE 18X1-1/2 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: 22884302
• Report Number: 1911916-2025-00611
• Device Sequence Number: 18542885
• Product Code: FMI
• UDI-Device Identifier: 00382903051960
• UDI-Public: (01)00382903051960(11)250402(17)300430(10)5092808
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 305196
• Device Lot Number: 5092808
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown