MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 18X1IN BLUNT FILL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305181
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle 18x1in blunt fill had epoxy on the needle.The following information was provided by the initial reporter: material#: 305181, lot#: 5174823.Rcc received a complaint via email.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.A report was received regarding defective blunt fill needles.To support the investigation, one sample with an opened packaging blister and two photographs were provided for evaluation by the quality team.A visual inspection revealed that the needle exhibited an epoxy drip measuring approximately 1/4 inch in length, located about 3/16 inch from the needle tip.The photographs confirmed the condition observed in the returned sample.This issue could potentially occur if a jam occurred at the cannulator.A review of the device history record for material number: 305181, lot: 5174823, was conducted.The review did not identify 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 accordance with specification requirements.Verification of the cannulator settings confirmed they were correct, and product flow was normal.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.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 NEEDLE 18X1IN 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: 23723472
• Report Number: 1911916-2025-00778
• Device Sequence Number: 18790454
• Product Code: GAA
• UDI-Device Identifier: 00382903051816
• UDI-Public: (01)00382903051816(11)250623(17)300630(10)5174823
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: 305181
• Device Lot Number: 5174823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown