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

Catalog Number	305195
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd needle 18x1 rb had foreign matter.The following information was provided by the initial reporter: material # 305195.Batch # 5202809.Verbatim: pharmacy technician found needle contaminate with black substance in packaging.18g x1" needle.Lot 5202809, exp 07/31/2030.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation it was reported that a needle was contaminated with a black substance inside its packaging.To support the investigation, one sealed blister-packaged sample and a photograph were provided for evaluation by the quality team.A visual inspection revealed a dark-colored dust particle located between the top and bottom packaging layers.The photograph confirmed the condition observed in the returned sample.No additional defects or imperfections were identified.This issue may have occurred if the particle was not removed following maintenance or repair of the packaging equipment.A review of the device history record for material number 305195, lot 5202809, was completed.The review did not indicate any quality issues during production that could have contributed to the reported condition, and no related quality notifications were found.All processes and final inspections were performed in compliance with specification requirements.The sample will be shared with associates for awareness.To date, no other similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer¿s 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: 23548975
• Report Number: 1911916-2025-00741
• Device Sequence Number: 9530842
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954(17)300731(10)5202809
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 305195
• Device Lot Number: 5202809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown