MAUDE Adverse Event Report: BECTON DICKINSON AND CO. SHARPS CONTAINER 1.4 QT HOME; CONTAINER, SHARPS

Model Number 323487

Device Problem Difficult to Open or Close (2921)

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

Event Type  malfunction  

Event Description

Email attached to complaint.Sent: (b)(6) 2024 9:38 am- (b)(6) awareness date.Sent: (b)(6) 2023 1:05 pm- (b)(6) awareness date.I am having gret difficulty trying to close up my home sharps container.Also, once you close it, can you reopen it? i purchased mine from a walmart i believe; it has a lot number of 1124001, upc code number (b)(4).Thank you.

Manufacturer Narrative

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: SHARPS CONTAINER 1.4 QT HOME
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): BECTON DICKINSON AND CO.
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18637139
• MDR Text Key: 335431084
• Report Number: 2243072-2024-05001
• 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: K943139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 323487
• Device Lot Number: 1124001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2023
• Initial Date FDA Received: 02/03/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1