MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 23X1-1/2 RB TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305194
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/26/2024
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#: 305194, batch#: 4159481.The doctor was injecting medication into the patient's cervix using a 12ml control syringe with a needle extender and a 23g hypo attached to the end.When removing the injection apparatus from the vaginal cavity, it was noted that the metal hypo portion of the needle was not attached to the plastic portion of the hypo hub (broken off).The doctor examined the cervix and noted the hypo imbedded in tissue.Used an instrument to remove the broken hypo.The hypo (metal and hub) was compared to a new (same) hypo, where it was determined that they lengths were the same.Also noting the bevel end and the broken end distinctively.Additional info: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No injury can you please provide an exact date of event in format dd-mmm-yyyy? 11-26-2024.Total number of occurrences? just 1.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? unfortunately, there was no sample available.
Additional Manufacturer Narrative
(b)(4).Follow up a device history record review was completed by our quality engineer team for provided material number 305194 and lot number 4159481.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
Event or Problem Description
No additional information received.

• Brand Name: NEEDLE 23X1-1/2 RB TW
• 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: 21421497
• Report Number: 1911916-2025-00133
• Device Sequence Number: 15394484
• Product Code: FMI
• UDI-Device Identifier: 30382903051947
• UDI-Public: (01)30382903051947(11)240607(17)290731(10)4159481
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 305194
• Device Lot Number: 4159481
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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