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

Catalog Number	305128
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material# 305128 batch# 3024960 it was reported by customer that needle in the box would not release the medication, and every 3rd needle or so will not stay on the syringe.Bd precisionglide needle 30g x 1, #305128 with lot#3024960, is reported to be defective my a physician office placing botox injections.At least 1 needle in the box would not release the medication, and every 3rd needle or so will not stay on the syringe.Staff are flushing with saline prior to drawing up and administering the rx.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation it was reported the needle would not release the medication and every third needle or so will not stay on the syringe.To aid in the investigation, three hundred samples were received for evaluation by our quality team.Two hundred ninety-seven samples came in sealed packaging blisters and three samples came in opened packaging blisters.Eighty samples were randomly selected for investigation.A visual inspection was performed, and no defects or imperfections were observed.Each of the eighty samples were then connected to a syringe with saline solution.Seventy-eight samples expelled the solution with a normal flow.The other two samples came in the opened packaging blisters and 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.No connectivity issues were observed.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 could not be confirmed.
Event or Problem Description
Additional information received: no patient harm: material# 305128 batch# 3024960 it was reported by customer that needle in the box would not release the medication, and every 3rd needle or so will not stay on the syringe.Verbatim: bd precisionglide needle 30g x 1, #305128 with lot#3024960, is reported to be defective my a physician office placing botox injections.At least 1 needle in the box would not release the medication, and every 3rd needle or so will not stay on the syringe.Staff are flushing with saline prior to drawing up and administering the rx.

• 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: 19250209
• Report Number: 1911916-2024-00325
• Device Sequence Number: 17976167
• Product Code: FMI
• UDI-Device Identifier: 30382903051282
• UDI-Public: (01)30382903051282
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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: 04/25/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/13/2024
• 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