MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 18X1-1/2 BLUNT FILL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305180
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle 18x1-1/2 blunt fill had foreign matter.The following information was provided by the initial reporter: material #305180 lot #5092742 verbatim: rcc received a complaint via email.Took bd blunt fill needle out of packaging and found white buildup on needle prior to use.Product workday itm-number: itm-1092552, lot number: 5092742, supplier & supplier reference/re-order or item number: bd ref: 305180 expiration date: 2030-05-31.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.It was reported there was white buildup on the needle.Our quality team has completed a device history record review for material number 305180 and lot number 5092742.The review did not identify any abnormalities during the production process that could have contributed to the defect, and all quality tests were within specification.Due to the unavailability of a sample for return, a comprehensive sample investigation could not be conducted.Consequently, the exact cause of this incident remains undetermined.At this time, no further action is deemed necessary.Complaints related to this device and the reported condition will continue to be monitored and analyzed for emerging trends by our quality team.

• Brand Name: BD NEEDLE 18X1-1/2 BLUNT FILL
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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: 23772606
• Report Number: 1911916-2025-00786
• Device Sequence Number: 13109712
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: (01)00382903051809(11)250402(17)300531(10)5092742
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 305180
• Device Lot Number: 5092742
• 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: 11/19/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown