MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR; NEEDLE HYPODERMIC SINGLE LUMEN

Catalog Number	305487
Medical Device Problem Codes	Product Quality Problem (1506); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
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 bd sharps collector lid will not shut.The following information was received by the initial reporter with the following verbatim.This is a complaint about the temporary lid won't close during use.
Event or Problem Description
Sample.
Additional Manufacturer Narrative
One sample was received and tested by our quality team with the customer's complaint of lid issues.The lid was locked upon receipt and the complaint could not be verified.The root cause of this issue is unknown and the device is functioning as intended.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Sample.
Additional Manufacturer Narrative
One sample was received and tested by our quality team with the customer's complaint of lid issues.The lid was locked upon receipt and the complaint could not be verified.The root cause of this issue is unknown and the device is functioning as intended.

• Brand Name: BD SHARPS COLLECTOR
• Common Device Name: NEEDLE HYPODERMIC SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23489968
• Report Number: 2243072-2025-01362
• Device Sequence Number: 4758324
• Product Code: FMI
• UDI-Device Identifier: 00382903054879
• UDI-Public: (01)00382903054879(10)4243973
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• 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,Followup,Followup
• Report Date (Section B): 01/12/2026

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: 305487
• Device Lot Number: 4243973
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 01/09/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/09/2026; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown