MAUDE Adverse Event Report: BECTON DICKINSON BD¿ HOME SHARPS CONTAINER; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	323487
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 8 bd¿ home sharps container lids were missing.It was reported by the customer that they are missing lids.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.The manufacturing location for this product is premium plastic solution.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.
Additional Manufacturer Narrative
Investigation summary: no samples were returned therefore the investigation was performed based on the photos provided.Two photos were provided.The customer reported that they are missing lids.The photos were examined, and it was observed that the sharps container was inside of a shelf carton, however, it could not be determined from the photos provided alone if the lid was missing.Unable to perform a dhr review for missing lids due to unknown lot number.Embecta was not able to duplicate or confirm the customer¿s indicated failure based on the photos received root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that 8 bd¿ home sharps container lids were missing.It was reported by the customer that they are missing lids.Missing lids.

• Brand Name: BD¿ HOME SHARPS CONTAINER
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15913639
• Report Number: 2243072-2022-02089
• Device Sequence Number: 4397766
• Product Code: FMI
• UDI-Device Identifier: 50382903234870
• UDI-Public: 00382903234875
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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: 323487
• Device Catalogue Number: 323487
• Device Lot Number: UNKNOWN
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown