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

Catalog Number	305196
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A white substance was reported on several needles.To support the investigation, three samples and three photographs were submitted for evaluation by the quality team.One sample was received in an opened blister package, while the other two were in sealed blister packages.A visual inspection was conducted, revealing that the sample in the opened blister had an epoxy drip on the needle hub.The three photographs provided depicted one of the returned samples.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 for material number 305196, lot 5029970, was completed.The review did not identify any quality issues during production that could have contributed to the reported condition, nor were there any related quality notifications.All processes and final inspections were performed in accordance with specification requirements.Verification of the cannulator confirmed that the settings were correct and product flow was normal.Based on the investigation and analysis of the returned sample, 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 18x1-1/2 rb had excessive epoxy.The following information was provided by the initial reporter: material#: 305196batch#: 5029970.1.Send a transport tube for shipping a sample to the following address: a white substance is found on some of the needles: our clinicians observed the presence of a white substance on some of the needles (photos attached).No patients were affected.The boxes from this batch have been removed from use and set aside by the intensive care team.Send a transport tube for shipping the sample to the following address.

• 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: 23799571
• Report Number: 1911916-2025-00799
• Device Sequence Number: 8954781
• Product Code: FMI
• UDI-Device Identifier: 00382903051960
• UDI-Public: (01)00382903051960(11)250129(17)300405(10)5029970
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2025

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: 305196
• Device Lot Number: 5029970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown