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	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A black mark was reported on an 18g needle.As the physical sample was not returned, a comprehensive evaluation could not be conducted.To support the investigation, two photographs were provided and reviewed by the quality team.The first image depicts the needle assembly removed from its blister packaging, with the plastic shield taken off, revealing a dark discoloration on the needle.The second image shows the top web of the packaging blister.No additional defects or irregularities were observed.A review of the device history record was completed for material number: 305196, lot: 5029974.The assessment did not identify any quality issues during the production of this lot that could be associated with the reported condition.No related quality notifications were found, and all manufacturing processes and final inspections were performed in accordance with specification requirements.Based on the investigation and photographic evidence, the reported symptom has been confirmed.However, in the absence of the physical sample, it is not possible to determine a probable root cause.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 foreign matter.The following information was provided by the initial reporter: material#: 305196, batch#: 5029974.Rcc received a complaint via email.There is a black mark on bd 18g needle our team member noticed upon opening.Needle was not used.Incident date: on (b)(6) 2025.305196, 5029974.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.A black mark was reported on an 18g needle.To support the investigation, one sample in a sealed blister package and two photographs were provided and reviewed by the quality team.A visual inspection was conducted, revealing a dark-colored embedded speck located approximately 5/16 inch from the bottom of the needle hub.The first image shows the needle assembly removed from its blister packaging, with the plastic shield removed, exposing a dark discoloration on the needle.The second image depicts the top web of the blister packaging.No additional defects or irregularities were observed.The embedded degraded resin in the component typically occurs during startup or intermittently throughout the injection molding process.This degraded resin can break loose and become incorporated into molded components.A review of the device history record for material number 305196, lot 5029974, was completed.The assessment did not identify any quality issues during the production of this lot that could be associated with the reported condition.No related quality notifications were found, and all manufacturing processes and final inspections were performed in accordance with specification requirements.The sample will be shared with associates for awareness.Based on the investigation and analysis of the returned sample, the customer-reported condition has been confirmed.

• 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: 23501126
• Report Number: 1911916-2025-00729
• Device Sequence Number: 8993492
• Product Code: FMI
• UDI-Device Identifier: 00382903051960
• UDI-Public: (01)00382903051960(10)5029974
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 5029974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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