MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL PRECISIONGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305128
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported, the needle broke off into the patient.The md was made aware.Md performed ultrasound guided excision to remove the needle tip but did not see the needle in excised tissue.Tissue was sent to the lab.Patient was transferred to emergency department to provide further assistance with foreign body removal.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.E4.The initial reporter also notified the fda on 2026 march.Medwatch report is (b)(4).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Additional information: h.Attached medsun.Investigation summary: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.

• Brand Name: PRECISIONGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 24940422
• Report Number: 1911916-2026-00182
• Device Sequence Number: 5663495
• Product Code: FMI
• UDI-Device Identifier: 00382903051281
• UDI-Public: (01)00382903051281(17)301231(10)6004462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 305128
• Device Lot Number: 6004462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2026
• 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 Age: 70 YR
• Patient Sex: Male