MAUDE Adverse Event Report: BECTON DICKINSON SHARPS CONTAINER 1.4 QT HOME; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	323487
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) has been used as a default.Device manufacture date: unknown.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.
Event or Problem Description
It was reported that sharps container 1.4 qt home lid was permanently closed.The following information was provided by the initial reporter: it was reported by the consumer, the home sharps container had the lid permanently closed.  verbatim: i returned consumer's call, she stated that she was driving and would call back.Before disconnecting the call, she stated that she was able to force the lid open, just hoping that it will close properly when it is filled.Consumer did not have lot number available.Voicemail: consumer left voicemail reporting that she purchased a home sharps container and the permanent lid was closed.

• Brand Name: SHARPS CONTAINER 1.4 QT HOME
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12610752
• Report Number: 2243072-2021-02487
• Device Sequence Number: 3431557
• Product Code: FMI
• UDI-Device Identifier: 00382903234875
• UDI-Public: 00382903234875
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K072105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: Lay User/Patient
• Device Model Number: 323487
• Device Catalogue Number: 323487
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1