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	04/04/2025
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
Material # 305198 batch # 4159528, unknown,4116660.It was reported by the customer that the cement on the conjunction of the hub and needle is loose and breaks, causing contamination.Verbatim: rcc received a complaint via phone.Pir attached customer states that their 16g needles have cement running down the needle and causes contamination.Sometimes the cement on the conjunction of the hub and needle is loose and breaks as well.3 lots are affected.Customer has samples and pictures and videos to send it as well.Additional information lot # 4064535 ¿ apologies for the confusion.This should be lot # 4064635 date of discovery ¿ 04-04-2025 harm, injuries, complications, neg.Outcomes ¿ none of which we are aware we have quarantined the affected lots in our pharmacy and will work to ship them to bd with the provided label today or tomorrow (along with several bags of needles that were discovered with the issue in question).
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported the cement on the conjunction of the hub and needle is loose and breaks.To aid in the investigation, one thousand two hundred fifty samples were received for evaluation by our quality team.One thousand forty-five samples came in sealed packaging blisters and five samples came in opened packaging blisters.Two hundred samples were randomly selected for investigation.A visual inspection was performed.One sample in an opened packaging blister from lot 4159528 was found with an epoxy drip over on the needle hub.This condition occurs if there is a jam at the cannulator.A device history record review was completed for provided material number 305198, lots 4159528, 4064635 and 4116660.The review did not reveal any detected quality issues during the production of these lots 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.To date, there have been no other similar events reported for these lots.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: 21848688
• Report Number: 1911916-2025-00284
• Device Sequence Number: 7954158
• Product Code: FMI
• UDI-Device Identifier: 30382903051985
• UDI-Public: (01)30382903051985(11)240304(17)290430(10)4064635
• 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: Health Professional
• 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: 4064635
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown