MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305196
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported incorrect label.Event description: material#: 305196; batch#: 5065323.Description of claim: packing list shows 50 cases of batch 5065323 shipped, however upon inspection we found one case doubled labeled with two different lot numbers referenced on the exterior of the box.See attached photos for the labels showing batch 5065323 and 5065622, the actual batch shipped in the box were for 5065323.
Additional Manufacturer Narrative
H11 -a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Additional Manufacturer Narrative
(b)(4) follow up.A case was reported to have been double labeled with two distinct lot numbers on the exterior of the box.To support the investigation, two photographs were submitted for evaluation by the quality team.Each image depicts a case box with a shelf box placed on top.One case box is labeled with lot number 5065322, while the shelf box displays lot number 5065323.No additional information could be extracted from the photographs.This labeling discrepancy may have occurred due to the incorrect application of a label on the packaging box.A review of the device history record (dhr) was conducted for material number 305196, lot 5065323.The review did not identify any quality issues during the production of this lot that could have contributed to the reported condition.No related quality notifications were found.All manufacturing processes and final inspections were performed in accordance with specification requirements.The packaging process was verified, and labeling was confirmed to be accurate.Associates were informed of the event.Based on the investigation and analysis of the submitted photographs, the reported labeling discrepancy has been confirmed.

• Brand Name: NEEDLE 18X1-1/2 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 22687507
• Report Number: 1911916-2025-00550
• Device Sequence Number: 13048771
• Product Code: FMI
• UDI-Device Identifier: 00382903051960
• UDI-Public: (01)00382903051960(11)250306(17)300430(10)5065323
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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,Followup
• Report Date (Section B): 08/08/2025

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: 305196
• Device Lot Number: 5065323
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown