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

Model Number	323487
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Missing Information (4053)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Date of event: unknown.Medical device expiration date: unknown the customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that sharps container 1.4 qt home was missing label information.The following information was provided by the initial reporter: material no:323487, batch no: unknown.It was reported that the consumer is upset because this product is labeled as a "mail back sharps container bd sharps disposal by mail" and it did not come with the mail back box or instructions.
Event or Problem Description
It was reported that sharps container 1.4 qt home was missing label information.The following information was provided by the initial reporter: material no:323487 batch no: unknown.It was reported that the consumer is upset because this product is labeled as a "mail back sharps container bd sharps disposal by mail" and it did not come with the mail back box or instructions.
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr check for label information missing due to unknown lot number.H3 other text : see h10.

• 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: 11298531
• Report Number: 2243072-2021-00263
• Device Sequence Number: 12001681
• 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: K943139
• 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,Followup
• Report Date (Section B): 05/07/2021

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
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1