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	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Bd 30g needle cannot withdraw and also cannot deliver the drug fluid.Look like its bore hole is blocked.It happened when they are withdrawing the drugs.They changed to other one, this new one can withdraw and can injecting the medicinal fluid to the patient.But, in the other occasion the needle also cannot inject the medicinal fluid.Total about 8 pieces bd needle that experience this case.We provided video comparator of bd needle 30g versus original needle of 1ml syringe when withdraw and deliver fluid.When testing used normal saline the bd 30g cannot withdraw and deliver the fluid as seen in the video.
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported the needle cannot withdraw or deliver the drug fluid.To aid in the investigation, one video was provided for evaluation by our quality team.The video shows a person with a needle assembled to a syringe and a container with a clear solution.When trying to withdraw the solution, it is not possible.No other information could be obtained from the video.A device history record review was completed for provided material number 305107, lot 3083960.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.To date, there have been no other similar events reported for this lot.Based on the investigation and with the video sample analysis the symptom reported by the customer is confirmed.Without the actual sample analysis, a probable root cause could not be offered.
Event or Problem Description
No additional information received.Bd 30g needle cannot withdraw and also cannot deliver the drug fluid.Look like its bore hole is blocked.It happened when they are withdrawing the drugs.They changed to other one, this new one can withdraw and can injecting the medicinal fluid to the patient.But, in the other occasion the needle also cannot inject the medicinal fluid.Total about 8 pieces bd needle that experience this case.We provided video comparator of bd needle 30g versus original needle of 1ml syringe when withdraw and deliver fluid.When testing used normal saline the bd 30g cannot withdraw and deliver the fluid as seen in the video.

• 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: 20180512
• Report Number: 1911916-2024-00664
• Device Sequence Number: 8298432
• Product Code: FMI
• UDI-Device Identifier: 00382903051076
• UDI-Public: (01)00382903051076(11)230324(17)280430(10)3083960
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 3083960
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown