MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 21X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305167
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.A discrepancy was reported between the labeling on the syringes and the information provided on the certificate of compliance and outer packaging.To support the investigation, five photographs were submitted for evaluation by the quality team.These images included the packaging blister top webs, a bd certificate, a customer document, and a packaging shelf box label.Notably, the blister top web displayed an expiration date of march 31, 2030, while both the bd certificate and the packaging shelf box label indicated an expiration date of march 31, 2029.This inconsistency may have resulted from an incorrect expiration date being entered during the setup process.A review of the device history record was conducted for material number 305167, lot 5064179.The review did not identify any quality issues during the production of this lot that could have contributed to the reported discrepancy.No related quality notifications were found, and all processes and final inspections were performed in accordance with specification requirements.To raise awareness, the photographs will be shared with associates, and the certificate will be updated to reflect the correct expiration date of march 31, 2030.Based on the investigation and analysis of the photographic evidence, the condition reported by the customer 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 21x1-1/2 rb label content was incorrect.The following information was provided by the initial reporter: material # 305167.Batch # 5064179.Verbatim: rcc received a complaint via email.Can you please review the attached pdf document and let me know why the expiration dates are different on this item? we have an expiration date discrepancy for item 305167 po # (b)(6).The label on the syringes itself has an expiration date of 2030-03-31 but the certificate of compliance from bd and the outer box have an expiration date of 2029-03-31.Could you please provide a document explaining the difference between these two expiries for the same bd lot?.

• Brand Name: BD NEEDLE 21X1-1/2 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 23532707
• Report Number: 1911916-2025-00736
• Device Sequence Number: 15724214
• Product Code: FMI
• UDI-Device Identifier: 00382903051670
• UDI-Public: (01)00382903051670(17)300331(10)5064179
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: 305167
• Device Lot Number: 5064179
• 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: 10/23/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown