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

Model Number	9601
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is premium plastic solutions.This site is an oem manufacturing site.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the pen needle was difficult to detach from the insulin pen into the bd¿ home sharps container.The following information was provided by the initial reporter: "consumer reported she is unable to remove the pen needle from her insulin pen into the bd home sharps container.Stated she can remove the pen needle easily with her fingers but it will not go into the sharps container.".
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Dhr was performed.No ncr's were raised during the production of this lot, all testing was within specification.
Event or Problem Description
It was reported that the pen needle was difficult to detach from the insulin pen into the bd¿ home sharps container.The following information was provided by the initial reporter: "consumer reported she is unable to remove the pen needle from her insulin pen into the bd home sharps container.Stated she can remove the pen needle easily with her fingers but it will not go into the sharps container.".

• Brand Name: BD HOME SHARPS CONTAINER
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11441185
• Report Number: 2243072-2021-00719
• Device Sequence Number: 4048529
• Product Code: FMI
• UDI-Device Identifier: 10885403960109
• UDI-Public: 10885403960109
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 9601
• Device Catalogue Number: 323487
• Device Lot Number: 0301001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1