MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 23X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305194
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
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#:305194, batch#:3347792.We experienced another one of our xxxxxxxxxxxxxxx location having the same issue with the same product.Are you able to do the same process we did with the other locations we just did to this one below that just experienced this issue.We have had issues with the bd needles not pushing medication out.My medical assistants have said there have been about 3-5 a day where they went to inject the medication and nothing was pushing out.The lot number is 3347792.I attached a picture and video of the instance happening.This is causing a patient to have to be stuck twice because of this.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported the needles would not push medication out.To aid in the investigation, seven samples in sealed packaging blisters, one photo and one video was provided for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then assembled to a syringe with saline solution.All the samples expelled the solution with a normal flow.The video shows a needle assembled to a syringe with a human hand push the plunger rod in.No solution is observed coming out of the needle tip.The photo provided shows a packaging blister top web.No other information could be obtained from the photo.A device history record review was completed for provided material number 305194, lot 3347792.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
No additional information received.

• Brand Name: NEEDLE 23X1-1/2 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: 20825032
• Report Number: 1911916-2024-00862
• Device Sequence Number: 8843334
• Product Code: FMI
• UDI-Device Identifier: 30382903051947
• UDI-Public: (01)30382903051947(11)231213(17)290228(10)3347792
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/19/2024

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: 305194
• Device Lot Number: 3347792
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown