MAUDE Adverse Event Report: BECTON DICKINSON PRECISIONGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305106
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2025
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material #305106.Lot #unknown.His sister who has endometriosis had a gynecological procedure where they were injecting botox and the needle broke.Verbatim: rcc received a complaint via call.Requesting if the precision glide needle (ref 305106) contains stainless steel or any ferrous metals.His sister who has endometriosis had a gynecological procedure where they were injecting botox and the needle broke.They can see the 6mm piece in x-ray but have been unsuccessful in removing it.She has had two exploratory procedures so far.Additional information 1.Can you please provide an exact date of event in format dd-mmm-yyyy? 2023.2.Can you please provide the lot number associated with reported issue? na.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Yes, the needle broke off inside the patient during a gyn procedure.The patient is still needing to have needle removed and was inquiring about the types of material the product is made with.
Additional Manufacturer Narrative
(b)(4) follow up: it was reported the needle broke.Due to the absence of a physical sample, photographic evidence, or lot number, our quality engineering team was unable to conduct a comprehensive investigation.Current quality controls are in place to identify such defects during the production process.Based on the limited investigation, the cause of the reported incident remains undetermined.If you encounter any further issues with our product, we would appreciate the opportunity to perform a thorough analysis.Examination of the involved product may provide insights into the cause of the reported failure.

• Brand Name: PRECISIONGLIDE
• 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: 22208674
• Report Number: 1911916-2025-00416
• Device Sequence Number: 8262339
• Product Code: FMI
• UDI-Device Identifier: 30382903051060
• UDI-Public: (01)30382903051060
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305106
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/15/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown