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	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that an incorrect lot number appeared on the dispenser boxes.To support the investigation, three photographs were provided for evaluation by the quality team.The first photograph shows a packaging case box label with lot number 5213846, the second shows an individual blister package with the same lot number, and the third displays a shelf box label with lot number 5029287.This discrepancy could occur if the wrong lot number was applied to the shelf box label.A device history record review was conducted for material number 305180, lot 5213846.The review did not identify any quality issues during production that could have contributed to the reported condition.No related quality notifications were found, and all processes and final inspections were performed in accordance with specification requirements.Associates have been informed of this event.To date, no similar occurrences have been reported for this lot.Based on the investigation and analysis of the photographic evidence, the customer¿s reported issue 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.
Event or Problem Description
It was reported that the bd needle 18x1-1/2 blunt fill label content was incorrect.The following information was provided by the initial reporter: material # 305180 lot # unknown verbatim: rcc received a complaint via email.Email(s) attached.Busse item # 1593a ¿ (18g x 1.50 sterile blunt needle) bd item # 305180 lot # 5213845 po 92179 qty received/rejected: 6 cases (b)(4) pcs) date received: 11/17/2025.Reason of rejection: incorrect lot number on the dispenser boxes ¿ see photo attached.During our incoming inspection, our qa inspector noted a discrepancy between the lot numbers: the shipper carton and unit are labeled lot # 5213846, while the dispenser boxes are labeled lot # 5029287.

• 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: 23796836
• Report Number: 1911916-2025-00793
• Device Sequence Number: 13379808
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: (01)00382903051809(11)250801(17)300731(10)5213845
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: 305180
• Device Lot Number: 5213846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown