MAUDE Adverse Event Report: BECTON DICKINSON BD¿ SHARPS COLLECTOR; SHARPS CONTAINER

Catalog Number 300460

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/12/2023

Event Type  malfunction  

Event Description

It was reported that 50 bd¿ sharps collectors each from lots 2208001 and 2306002 had issues with the lids not staying closed.The following information was provided by the initial reporter: "lids do not stay closed.At the slightest pressure of the container the lid opens.The nurses move around with her containers full of dirty needles.".

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is flextronics.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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2208001.Medical device expiration date: na.Device manufacture date: 04-aug-2022.Medical device lot #: 2306002.Medical device expiration date: na.Device manufacture date: 09-nov-2022.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: no product or photo was returned by the customer.It was reported by the customer that lids do not stay closed could not be verified due to the product not being returned for failure investigation.The lids should be properly installed and remain latched if used as intended.Based upon the information provided, it seems the product was not being used as intended.A device history review was conducted for lot numbers 2208001 and 2306002.

Event Description

It was reported that 50 bd¿ sharps collectors each from lots 2208001 and 2306002 had issues with the lids not staying closed.The following information was provided by the initial reporter: "lids do not stay closed.At the slightest pressure of the container the lid opens.The nurses move around with her containers full of dirty needles.".

• Brand Name: BD¿ SHARPS COLLECTOR
• 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 ; 8015296192
• MDR Report Key: 16301801
• MDR Text Key: 308962681
• Report Number: 2243072-2023-00136
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300460
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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