MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305343
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
This is a report about the sharps collector's lid that doesn't shut properly.When using it, customer tried to join the lid and the main body, but there was one place out of the four corners where the fit was poor, and the lid would not close.
Additional Manufacturer Narrative
Investigation summary: device received in bd japan.Evaluated and verified complaint of lid issues.Root cause found to be unknown after contacting supplier but most likely root cause due to improper handling.
Event or Problem Description
Samples received.

• Brand Name: SHARPS COLL 8QT NEST OPEN TOP NEEDL PORT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20798731
• Report Number: 2243072-2024-01177
• Device Sequence Number: 20541291
• Product Code: FMI
• UDI-Device Identifier: 00382903053438
• UDI-Public: (01)00382903053438(11)240514(10)4121912
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: 305343
• Device Lot Number: 4121912
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown