MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30X1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305106
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description: material #:305106, batch#:4116510.Verbatim: rcc received a complaint via email.Email(s) attached.We have been having an issue with the bd precisionglide needle where we have a second stream exiting from the side of the needle when we inject.We encountered the issue a second time today after initially having this issue about a month ago.The lot number is 4116510.Additionally, there have been other times, perhaps 3, when the needle feels like it is plugged and we are unable to inject the medication.Please let me know if there is any other information we can provide.Date of event was on thursday, (b)(6) 2025.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event n/a.
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
Pr (b)(4) follow up for device evaluation.It was reported there is a second stream exiting from the side of the needle and the needle feels like its plugged.To aid in the investigation, one sample with no packaging blister and one photo was received for evaluation by our quality team.A visual inspection was performed; first, with 10x magnification and then with 30x magnification.There is a short shot in the molding 5/16" from the bottom of the needle hub.The sample was assembled to a syringe with saline solution.The solution expelled through the needle tip and through the needle hub short shot.The photo provided shows the sample received.No other defects or imperfections were observed.This condition occurs if there is a variation with the stripping bushing of the molding tool.A device history record review was completed for provided material number 305106, lot 4116510.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.The sample will be shown to associates for awareness.Based on the investigation with the returned sample analysis the symptom of leakage reported by the customer is confirmed.

• Brand Name: NEEDLE 30X1/2 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: 21706862
• Report Number: 1911916-2025-00244
• Device Sequence Number: 4745595
• Product Code: FMI
• UDI-Device Identifier: 30382903051060
• UDI-Public: (01)30382903051060(11)240425(17)290630(10)4116510
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/15/2025

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: 305106
• Device Lot Number: 4116510
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• 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: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown