MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16X1 RB; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305197
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material #:305197.Batch#:4305182.It was reported by customer that a white substance shot out and it the pharmacist.Verbatim: rcc received a complaint via email.We received a report from our (b)(6) concerning an event they have experienced while using a needle hypo nonsafety str 16g x 1in (reference (b)(4)).The lot number is 4305182.The event date is 03.21.2025.No harm to the patient has been reported.The sample is sequestered to conduct an analysis to determine the root cause of the failure.Please let me know the next step.We are willing to send the sample.Please have an rma and mailer label sent to my attention.The complaint is described: upon opening a bd precision glide needle 16gx 1", a white substance shot out and it the pharmacist.Possible plastic.(b)(4).Thank-you.
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)(6).Follow up for device evaluation: it was reported, upon opening the needle, a white substance shot out.To aid in the investigation, one sample in an opened packaging blister was received for evaluation by our quality team.A visual inspection was performed, and the needle has a droplet of epoxy located 1/4" from the needle hub.No other defects or imperfections were observed.This condition occurs during the assembly process if there is a jam at the cannulator.A device history record review was completed for provided material number 305197, lot 4305182.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.Verification of the cannulator was performed.The settings were correct, and the flow of product was good.Based on the investigation with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: NEEDLE 16X1 RB
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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: 21708973
• Report Number: 1911916-2025-00247
• Device Sequence Number: 13247303
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978(11)241031(17)300131(10)4305182
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 305197
• Device Lot Number: 4305182
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/18/2025
• 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