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

Catalog Number	305106
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
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 # 305106, batch # 4116511.It was reported by the customer that many are plugged and won't work and some have a hole in the side so the lidocaine shoots out the side.Verbatim: just wanted to let you know that our 30 gauge needles haven't been the best quality.Many are plugged and won't work and some have a hole in the side so the lidocaine shoots out the side.I had this happen 3 times in the past 3 hrs this morning, but it has been a daily occurrence.Additional information received on 08apr2025.1.Could you please provide a further description of the issue "many are plugged and won't work"? our surgeon said that they are having consistent issues with this brand.30 gauge needles haven't been the best quality.Many are plugged and won't work and some have a hole in the side so the lidocaine shoots out the side.It happened 3 times in the past 3 hrs this morning, but it has been a daily occurrence." 2.Can you please provide the material number of the product associated with reported issue? your 305106, my oracle 102269.3.Can you please provide the lot number of the product associated with reported issue? the lot that is causing us issues is 4116511 and previously given to (b)(6).4.What was the impact to the patient? did not get full amount of lidocaine during first attempt additional information received on 09apr2025.What was the impact to the patient? if the needle is blocked, nothing comes out.I have to completely remove the needle and get a new one.If the needle has a hole in it, some will go in to the area i'm numbing and some will shoot out the side.I will notice and change the needle.I stop injecting if i notice this but the full amount will not go in.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No adverse events or serious injuries.
Additional Manufacturer Narrative
(b)(6).Follow up: a device history record review was completed by our quality engineer team for provided material number 305106 and lot number 4116511.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

• 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: 21814778
• Report Number: 1911916-2025-00274
• Device Sequence Number: 7568538
• Product Code: FMI
• UDI-Device Identifier: 30382903051060
• UDI-Public: (01)30382903051060(11)240425(17)290731(10)4116511
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: 4116511
• 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: 04/18/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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