MAUDE Adverse Event Report: BECTON DICKINSON BD¿ HOME SHARPS CONTAINER, 1.4 QUART

Catalog Number 323487

Device Problem Difficult to Open or Close (2921)

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

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

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 in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.D.4 device expiration date: na.H3.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, 1.4 quart lid was difficult to operate.The following information was provided by the initial reporter: consumer reported hard time closing the lid to container.This caller has neuropathy and not a lot of strength.This container does not have sharps in it as of yet.Informed caller to place lid onto container only when full.

Event Description

It was reported that the bd¿ home sharps container, 1.4 quart lid was difficult to operate.The following information was provided by the initial reporter: consumer reported hard time closing the lid to container.This caller has neuropathy and not a lot of strength.This container does not have sharps in it as of yet.Informed caller to place lid onto container only when full.

Manufacturer Narrative

H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD¿ HOME SHARPS CONTAINER, 1.4 QUART
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17654752
• MDR Text Key: 322330035
• Report Number: 2243072-2023-01533
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10885403960109
• UDI-Public: (01)10885403960109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943139
• 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,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 323487
• Device Lot Number: 3123001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1