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

Catalog Number	305107
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A black foreign particle was reported on the surface of the needle.To support the investigation, one sample without packaging and a photograph were provided for evaluation by the quality team.A visual inspection confirmed the presence of a dark speck attached to the needle approximately 1/8 inch from the top of the needle hub.The photograph corresponded to the sample received.No additional defects or imperfections were observed.The sample was submitted to a laboratory for analysis; however, the foreign matter was too small to be conclusively identified.A review of the device history record for material number 301507, lot 3299469, revealed no quality issues during production that could have contributed to the reported condition.There were no related quality notifications, and all 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 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 30ga 1/2in had foreign matter.The following information was provided by the initial reporter: during a routine procedure, black foreign matter was observed on the surface of the needle in use.The residue was noticed mid-treatment and appeared to be embedded or adhered to the needle shaft.The origin of the black substance is currently unknown.

• 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: 23655766
• Report Number: 1911916-2025-00764
• Device Sequence Number: 14644995
• Product Code: FMI
• UDI-Device Identifier: 00382903051076
• UDI-Public: (01)00382903051076(17)281231(10)3299469
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 11/06/2025

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: 305107
• Device Lot Number: 3299469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown