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

Catalog Number	305196
Medical Device Problem Codes	Nonstandard Device (1420); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
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.Batch: 4247148.Batch creation date: 09/03/2024.Batch expiration date: 11/30/2029.Full udi: (b)(4).Batch: 4212625.Batch creation date: 07/30/2024.Batch expiration date: 09/30/2029.Full udi: (b)(4).
Event or Problem Description
Material # 305196, batch # 4247148, 4212625, 3347887.Verbatim: patient harm: no.Event description: what the customers best guess is excess glue found under cap of 18g precision glide needle it was identified prior to use.I do have samples pulled that i can mail back.
Additional Manufacturer Narrative
(b)(4) follow up: it was reported there was excess glue found under the cap.To aid in the investigation, two photos were received for evaluation by our quality team.One photo shows three packaging blister top webs.The other photo shows two needle assemblies with no packaging blisters and the plastic shield removed; both needle assemblies have an epoxy drip over on 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 305196, lots 4247148, 4212625 and 3347887.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.Based on the investigation with the photo sample analysis the symptom reported by the customer is confirmed.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.An excess of glue was reported under the cap.To support the investigation, twelve samples and two photographs were submitted for evaluation by our quality team.The samples included two from lot 4247148, nine from lot 4212625, and one from lot 3347887.Two samples from lot 4212625 were received in opened packaging blisters, while the remaining samples were in sealed packaging blisters.Upon visual inspection, the samples exhibited an epoxy drip on the needle hub.One photograph depicted three packaging blister top webs, and the other showed two needle assemblies without packaging blisters and with the plastic shield removed; both needle assemblies had an epoxy drip on the needle hub.No additional defects or imperfections were observed.This condition is likely to occur during the assembly process if there is a jam at the cannulator.A device history record review was conducted for material number 305196, covering lots 4247148, 4212625, and 3347887.The review did not reveal any quality issues during the production of these lots that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections complied with specification requirements.Verification of the cannulator settings confirmed they were correct, and the product flow was satisfactory.Based on the investigation and analysis of the returned samples, the symptom reported by the customer 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: 21675962
• Report Number: 1911916-2025-00219
• Device Sequence Number: 18220365
• Product Code: FMI
• UDI-Device Identifier: 30382903051961
• UDI-Public: (01)30382903051961(11)231213(17)290228(10)3347887
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2025

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: 3347887
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 05/01/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/04/2025; 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown