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

Catalog Number	305107
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission for device evaluation.It was reported the fluid does not inject due to blocking.To aid in the investigation, five samples in sealed packaging blisters and two photos were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.All the samples expelled the solution with a normal flow.The two photos provided show the samples received.A device history record review was completed for provided material number 305107, 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 could not be confirmed.Without the actual physical sample analysis, a probable root cause could not be determined.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.H3 other text : see h10 manufacture narrative.
Event or Problem Description
When the user shoot thru needle, the fluid doesn't inject due to blocking.There is a no sample available so i would like to send same lot product.No patient harm.

• 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: 18694520
• Report Number: 1911916-2024-00084
• Device Sequence Number: 8357913
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

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: 01/29/2024
• Initial Report FDA Received Date: 02/13/2024
• 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