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

Catalog Number	305211
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the seal appeared incomplete or compromised.To support the investigation, two samples with opened packaging blisters and three photographs were provided for evaluation by the quality team.A visual inspection was conducted, and the seal between the top and bottom webs was found to be intact, with no defects or imperfections observed.The first photograph depicted a packaging blister top web, the second showed an opened packaging blister, and the third displayed an opened blister with foreign language text.No additional information could be obtained from the photographs.A review of the device history record was performed for material number 305211, lot 4276008.The review confirmed that no quality issues were detected during production that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections complied with specification requirements.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the returned samples, the reported symptom could not be 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 filter blunt fill 18x1-1/2 had a package integrity issue.The following information was provided by the initial reporter: a defect was identified in the sealing of the product packaging.The seal was found to be incomplete or compromised, potentially affecting product integrity and sterility.This issue was observed during routine inspection prior to distribution.

• Brand Name: BD NEEDLE FILTER BLUNT FILL 18X1-1/2
• 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: 23631221
• Report Number: 1911916-2025-00763
• Device Sequence Number: 9337159
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: (01)00382903052110(17)290930(10)4276008
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: NA
• 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: Other
• Device Catalogue Number: 305211
• Device Lot Number: 4276008
• 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: 11/03/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown