MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30GA 1/2IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305107
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
There is a hole in the hub, so the chemical liquid leaks out through the hole.No harm.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there is a hole in the hub.To aid in the investigation, eleven samples, one photo and one video were provided for evaluation by our quality team.Ten of the samples came in sealed packaging blisters and one sample came with no packaging blister.A visual inspection was performed and the sample with no packaging blister has a short shot around (b)(6)" from the bottom of the needle hub.Each sample was then connected to a syringe with saline solution.The sample with the short shot expelled solution through the needle and through the needle hub short shot.The photo and video provided show the sample with the symptom reported and confirmed.Previous investigations have confirmed a short shot from the molding has induced a similar symptom.After analyzing the molding tool, it was determined that wear in the stripper bushing could contribute to the defect.The stripper bushing was replaced in (b)(6) 2023.A device history record review was completed for provided material number 301507, lot 3055908.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 is confirmed.
Event or Problem Description
No additional information received.There is a hole in the hub, so the chemical liquid leaks out through the hole.

• Brand Name: NEEDLE 30GA 1/2IN
• 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: 18776895
• Report Number: 1911916-2024-00144
• Device Sequence Number: 11843496
• Product Code: FMI
• UDI-Device Identifier: 00382903051076
• UDI-Public: (01)00382903051076
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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: 305107
• Device Lot Number: 3055908
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown