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

Catalog Number	305197
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that excess white adhesive was present on the hub where the needle and hub meet.To support the investigation, five photographs were provided for evaluation by the quality team.One image shows the packaging blister top web, another depicts a needle assembly without a packaging blister or plastic shield, and the remaining three display two needle assemblies with plastic shields but without packaging blisters, along with visible epoxy overflow on the needle hub.No additional defects or imperfections were observed.This condition may occur if a jam occurs at the cannulator.A review of the device history record was completed for material number: 305197, lot: 5091510.The review confirmed that no quality issues were detected 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.Verification of the cannulator settings was performed, confirming that the settings were correct and product flow was normal.To date, no other similar events have been reported for this lot.Based on the investigation and analysis of the photo samples, the customer¿s reported observation has been confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd needle 16x1 rb had excessive epoxy.The following information was provided by the initial reporter: rcc received a complaint via phone.The white glue where the hub and needle meet is all over the hub of the product.

• Brand Name: BD 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: 23710774
• Report Number: 1911916-2025-00776
• Device Sequence Number: 10726854
• Product Code: FMI
• UDI-Device Identifier: 00382903051977
• UDI-Public: (01)00382903051977(17)300630(10)5091510
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/17/2025

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: 305197
• Device Lot Number: 5091510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown