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

Catalog Number	305128
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Materials#: 305128, batch#: 3024960.It was reported by the customer that the needles are completely clogged.Verbatim: rcc received a complaint via email.Pir attached.Complaint no.: (b)(4).Date of incident: (b)(6) 2024.Account number: (b)(4).Client's name: (b)(6).Product no.: 305128.Product description: bd 30gx1" needle.Serial no./lot: (b)(6).Quantity: 1 bx.Description: a dozen defective needles, the needles are completely clogged or with a scratched bevel.Response received.Please find below the requested information: no adverse events or serious injuries have been reported by patients or healthcare professionals.The needles need to be replaced either due to blockage or poor tissue penetration caused by clogged tip.
Additional Manufacturer Narrative
(b)(4): 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
Additional information received no adverse events or serious injuries have been reported by patients or healthcare professionals.The needles need to be replaced either due to blockage or poor tissue penetration caused by clogged tip.Materials#: 305128 batch#: 3024960 it was reported by the customer that the needles are completely clogged.Verbatim: rcc received a complaint via email.Pir attached.Complaint no.: (b)(4).Date of incident: (b)(6) 2024 account number: (b)(4).Client's name: (b)(6).Product no.: 305128 product description: bd 30gx1" needle serial no./lot: (b)(6).Quantity: 1 bx.Description: a dozen defective needles, the needles are completely clogged or with a scratched bevel.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported the needles are completely clogged or have a scratched bevel.To aid in the investigation, fifty-six samples were received for evaluation by our quality team.Forty-six samples were in sealed packaging blisters and ten samples had no packaging.A visual inspection was performed.First, with 10x magnification, and then with a 30x microscope.No defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.Fifty-four samples expelled the solution with a normal flow.Two samples did not expel the solution; these needles are clogged.It could be possible for this defect to occur while passing the needle through the stopper vial clogging the needle with the stopper vial material.A device history record review was completed for provided material number 305128, lot 3024960.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.There are quality controls currently in place to detect this type of defect during the production process such as a vision system that inspects 100% of all products for clogged needles.Based on the investigation and with the returned sample analysis the symptom reported by the customer of clogged needle is confirmed.

• Brand Name: NEEDLE 30X1 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: 18845656
• Report Number: 1911916-2024-00162
• Device Sequence Number: 20920619
• Product Code: FMI
• UDI-Device Identifier: 30382903051282
• UDI-Public: (01)30382903051282
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: 305128
• Device Lot Number: 3024960
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown