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
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 # 4305258.Verbatim: 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.Attached picture has lot and expiration date.Incident date: (b)(6) 2025.Needle is available to be returned for further investigation.
Additional Manufacturer Narrative
It was reported there was a black mark on the needle.As a physical sample was not returned, a thorough sample evaluation could not be performed.To support the investigation, three photographs were submitted for review by the quality team.Two of the images depict the top web of a packaging blister, while the third shows a large, transparent cylindrical object exhibiting discoloration.No additional information could be discerned from the photographs.A review of the device history record was completed for material number 305196, lot 4305258.The assessment did not identify any quality issues during the production of this lot that could be linked to the reported condition.No related quality notifications were found, and all manufacturing processes and final inspections were performed in accordance with specification requirements.To date, no similar events have been reported for this lot.Based on the investigation and the analysis of the submitted photographs, the reported symptom could not be confirmed.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.

• 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: 23493261
• Report Number: 1911916-2025-00727
• Device Sequence Number: 21049711
• Product Code: FMI
• UDI-Device Identifier: 00382903051960
• UDI-Public: (01)00382903051960(11)241031(17)300131(10)4305258
• 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: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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: 4305258
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown