MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PRECISIONGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305195
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
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 # 4270033 verbatim: rcc received a complaint via email.Email(s) attached.We use bd blunt fill needles and precision glide needles within our manufacturing process and wanted to reach out with a quick question for your team.As part of an internal investigation, we¿re assessing all possible sources of a stainless steel particle that was recently observed during product inspection.To help rule out potential contributors, could you please let us know if bd has any historical data, complaints, or awareness of instances where particulate shedding or residue from the manufacturing process has been observed on either of these needle types? at this stage, we¿re simply gathering background information to understand whether such occurrences have ever been reported or could be considered a possibility.Thank you very much for your time and support ¿ any information or references you can share from your quality or technical teams would be appreciated.Additional information provided: customer response received on 04nov2025 1.Can you please provide an exact date the reported issue was identified in mm-dd-yyyy format? 24sep2025 2.Can you please provide the material number and lot number of the bd blunt fill needle associated with reported issue? material #: 305180, lot #: 1117352.3.Can you please provide the material number and lot number of the precision glide needle associated with reported issue? material #: 305195, lot #: 4270033.4.Is there a photo or sample available for analysis? still trying to track down a picture?.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Additional information: (h) included device manufacture date.Investigation results: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.

• Brand Name: BD PRECISIONGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23512477
• Report Number: 3003916417-2025-00259
• Device Sequence Number: 13194850
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954(17)291231(10)4270033
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• 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: Other
• Device Catalogue Number: 305195
• Device Lot Number: 4270033
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown