MAUDE Adverse Event Report: BECTON DICKINSON BD¿ HOME SHARPS CONTAINER

Model Number 323487

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is premium plastic solutions.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.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd¿ home sharps container lid would not stay closed.The following information was provided by the initial reporter: "caller called to state that the sharps container he uses is full and he is not able to close the lid.The lid will not stay on.He has no directions on how to close it so he does not know if he is doing it correctly.".

• Brand Name: BD¿ HOME SHARPS CONTAINER
• Type of Device: SHARPS CONTAINER
• 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 ; 8448235433
• MDR Report Key: 16513244
• MDR Text Key: 310995371
• Report Number: 2243072-2023-00360
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00382903234875
• UDI-Public: 00382903234875
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 323487
• Device Catalogue Number: 323487
• Device Lot Number: 2132001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1