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

Catalog Number	305106
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using the needle 30 x 1/2 rb, leakage occurred, resulting in medication in doctor's eyes.The following was received by the initial reporter: customer reported when medication was pushed (lidocaine) the medication came out from the hub and luer lock connector resulting in medication getting in the doctor's eyes.This occurred in the er setting.Some needles seem to be clogged resulting in not drawling up medication.Additional information: the doctor has to flush his eyes.
Additional Manufacturer Narrative
It was reported that medication leaked from the hub and luer lock connector and that some needles appeared to be clogged.To support the investigation, sixty two samples in sealed blister packaging were received for evaluation by the quality team.A visual inspection identified no defects or imperfections.Each sample was then connected to a syringe and flushed with saline solution, all exhibited normal flow, and no leakage was observed at the luer connection.A device history record (dhr) review was completed for material number 305106, lot 4116509.The review did not reveal any quality issues during production that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections complied with specification requirements.Based on the investigation, including analysis of the returned samples, the customer¿s reported condition could not be confirmed.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.

• 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: 24769427
• Report Number: 1911916-2026-00144
• Device Sequence Number: 10267998
• Product Code: FMI
• UDI-Device Identifier: 00382903051069
• UDI-Public: (01)00382903051069(17)290630(10)4116509
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 03/24/2026

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: 305106
• Device Lot Number: 4116509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown