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

Catalog Number	323487
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed (b)(4).Is an oem manufacturing site.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the consumer was not able to open lid and instructions did not say it was unable to be opened once closed with a bd home sharps container.The following information was provided by the initial reporter: it was reported that consumer closed brand new container in error.Stated there are no instructions stating you can not open once it is closed.
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.Unable to perform dhr check for difficult/unable to operate (lid closed) due to unknown lot number.H3 other text : see h.10.
Event or Problem Description
It was reported that the consumer was not able to open lid and instructions did not say it was unable to be opened once closed with a bd home sharps container.The following information was provided by the initial reporter: it was reported that consumer closed brand new container in error.Stated there are no instructions stating you can not open once it is closed.

• 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: 9125384
• Report Number: 2243072-2019-02129
• Device Sequence Number: 16238263
• Product Code: FMI
• UDI-Device Identifier: 10885403960109
• UDI-Public: 10885403960109
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (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): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 323487
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other