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	11/17/2025
Type of Reportable Event	Malfunction
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
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.Verbatim: rcc received a complaint via email.We are once again experiencing coring issues with the bd blunt needles, item #305180.Please see the attached email and confirm how you would like us to proceed.Additional information provided: what is the brand/medication being used when coring is occurring? propofol mainly.Once it was observed with ancef.Is the same needle being used to puncture multiple vials? no, new for each vial.What angle is the needle entering the vial at: 90-degree or 45-degree angle? both, to see if it changes.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.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported there were coring issues.To support the analysis, three samples without packaging blisters were received for evaluation by the quality team.A visual inspection was conducted using 30x magnification, and no damage, defective grinding, or hooks were observed.The bevels and etching were found to be acceptable.Based on the investigation and the returned sample analysis, the symptom reported by the customer could not be confirmed.

• 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: 23738983
• Report Number: 1911916-2025-00780
• Device Sequence Number: 10464984
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown