MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR 14 QT MULTI-USE NESTABLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305464
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd sharps collector 14 qt multi-use nestable experienced a missing lid.The following information was provided by the initial reporter: we have a few containers that don¿t have lids.
Additional Manufacturer Narrative
H6: investigation summary no photo or sample was received with the customer's complaint of missing lids.Without any further evidence, the complaint cannot be verified and the root cause remains unknown.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
Event or Problem Description
It was reported that the bd sharps collector 14 qt multi-use nestable experienced a missing lid.The following information was provided by the initial reporter: we have a few containers that do not have lids.

• Brand Name: BD SHARPS COLLECTOR 14 QT MULTI-USE NESTABLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12097474
• Report Number: 2243072-2021-01794
• Device Sequence Number: 17334721
• Product Code: FMI
• UDI-Device Identifier: 00382903054640
• UDI-Public: 00382903054640
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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 Model Number: 305464
• Device Catalogue Number: 305464
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1