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	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported there were coring issues.Due to the absence of a physical sample, photographic evidence, or lot number, our quality engineering team was unable to conduct a comprehensive investigation.Current quality controls are in place to identify such defects during the production process.Based on the limited investigation, the cause of the reported incident remains undetermined.Examination of the involved product may provide insights into the cause of the reported failure.Complaints regarding this device and the reported condition will continue to be monitored and analyzed.Our quality team regularly reviews collected data to identify emerging trends.
Event or Problem Description
It was reported that the bd needle 18x1-1/2 blunt fill was coring.The following information was provided by the initial reporter: material#: 305180 batch#: unknown it was reported by the customer that once again experiencing coring issues with the bd blunt needles.Verbatim: rcc received a complaint via email.Email(s) attached.Additional info: 1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No adverse events noted 2.Can you please provide an exact date of event in format dd-mmm-yyyy 17-11-2025, 19-11-2025 3.Total number of occurrences? 4 4.Please confirm the lot number for the issue reported.Unable to provide lot number as package has been thrown out.

• 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: 23774739
• Report Number: 1911916-2025-00787
• Device Sequence Number: 16038579
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: (01)00382903051809
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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: UNKNOWN
• 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
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown