MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X5/8 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number 305122

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

Mat#: 305122.Batch#: 3024981.It was reported by the customer that they allege that multiple needles out of their 9cs order are leaking the needle meets the plastic portion.Customer has stopped using these units pending feedback on what to do with these units.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a0504 - leak / splash.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

Manufacturer Narrative

(b)(4).Follow up for device evaluation.It was reported multiple needles are leaking.To aid in the investigation, two samples with no packaging blisters were received for evaluation by our quality team.A visual inspection was performed with 10x magnification.There is a molding short shot a 5/16" from the bottom of the needle hub.Each sample was then connected to a syringe with saline solution and there was leakage from the short shot.No other defects or imperfections were observed.A device history record review was completed for provided material number 305122, lot 3024981.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.The samples will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

Event Description

(b)(4).Additional information received.  (b)(6) 2023.As indicated within the original complaint sent to you ¿ this complaint is not related to any patient or adverse effect.- please provide occurrence date.Not provided by customer.- what medication was used during the incident? not applicable.- is there any adverse event on patient? not applicable.- is there any medical intervention needed due to the incident? not applicable - is photo/sample or available for return? if yes, please confirm your address for return label.Not provided by customer.(b)(6) 2023.Please provide occurrence date.(b)(6) 2023 different days because it happens often.- what medication was used during the incident? no medication.- is there any adverse event on patient? no.- is there any medical intervention needed due to the incident? no.- is photo/sample or available for return? if yes, please confirm your address for return label.Yes i send you the photo but we also can send you some exemples.Note that we use this product to process radioactivity so it is a very big problem for us.The address to return label is 2655, av dalton , quebec g1p3s8.(b)(6) 2023 no worry, i have many samples on my desk.I will send as soon that i receive the labels.Mat#:305122 batch#:3024981.It was reported by the customer that they allege that multiple needles out of their 9cs order are leaking the needle meets the plastic portion.Customer has stopped using these units pending feedback on what to do with these units.Verbatim: rcc received the complaint via email.Email(s) as attached.Xxx alleges that multiple needles out of their 9cs order are leaking the needle meets the plastic portion.Customer has stopped using these units pending feedback on what to do with these units.

• Brand Name: NEEDLE 25X5/8 RB
• Type of Device: 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18082991
• MDR Text Key: 327492518
• Report Number: 1911916-2023-00826
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 305122
• Device Lot Number: 3024981
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1